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Ergomed


Founded in 1997, Ergomed provides specialist services to the pharmaceutical industry spanning all phases of clinical development, post-approval pharmacovigilance and medical information. Ergomed’s fast-growing services business includes an industry-leading suite of specialist pharmacovigilance (PV) solutions, integrated under the PrimeVigilance brand, a full range of high-quality clinical research and trial management services under the Ergomed brand (CRO), and an internationally recognised specialist expertise in orphan drug development, under PSR. In December 2020, Ergomed acquired MedSource, a US-based specialist oncology and rare disease CRO.

+30d

Cyber Security Engineer

ErgomedOccam Court, Occam Rd, Guildford GU2 7HJ, UK, Remote

Ergomed is hiring a Remote Cyber Security Engineer

Company Description

Ergomed plc is a public company listed on the London Stock Exchange, with its Headquarters in Guildford, Surrey.  The company employs more than 1,400 people across 20 offices globally. 

It is a rapidly growing and successful company.  This success is due to the hard work of our highly skilled employees and our subsequent reputation for excellence with our clients.

Job Description

The Cyber Security Engineer will be responsible for working with a range of tools and technologies in order to maintain a secure cloud-first computing environment globally in 20 offices.

This is a varied position that will allow you to work across the technology stack in the business.

You will ensure our business assets are protected in line with the corporate information security program and that compliance is achieved against a variety of technology regulations and requirements present in the pharmaceutical industry.

You will identify, evaluate, manage, remediate and report on information security risks across servers, endpoints, identities, data stores and the network.  Reporting directly to the Senior Director of Information Security, you will be part of a new team with the opportunity to contribute to how the job should be done.

As part of the new security operations team, you will liaise closely with infrastructure and support teams to ensure availability of systems is maintained while carrying out your security work.

The opportunity will suit someone who has performed in a desktop support role with exposure to enterprise-wide security tasks such as anti-virus, patching and endpoint management who would now like to add experience with servers and network devices, plus pure cyber skills, such as malware analysis, firewall and intrusion management to their CV.

The position would also suit someone with experience of working in a SOC who would now like more variety and closer contact with the technology.  This role will see you working with any and all of the various security products across the company.

Key Responsibilities:

·       Day to day oversight of the desktop and server patch program to ensure rapid remediation of all published Microsoft vulnerabilities affecting our IT estate.

·       Day to day management of the vulnerability scan program to ensure full visibility of vulnerabilities across all devices and software.

·       End to end malware management, from analysis to creation of blocking rules.

·       Assessment of new threats as alerted by our threat intelligence feeds.

·       Response to suspicious activity as part of incident response and security event management.

·       Creation and management of rules across the various management consoles deployed to secure the enterprise.

·       System access reviews to ensure the principle of least privilege is adhered to.

·       Mobile device management using Microsoft Intune/Endpoint Manager.

·       Reviewing, managing and remediating security alerts across the Microsoft Defender suite.

·       Creation and management of rules in Azure AD, such as MFA and conditional access.

·       Management of remote access granted to our third-party partners.

·       Windows desktop and Windows server security hardening.

·       Firewall rule management to ensure the principle of least privilege is maintained.

·       All other cyber security related tasks that arise from protecting an enterprise.

 

Qualifications

Technical cyber security qualifications would be preferred, such as Security+, CYSA+, CEH.

Any of the Microsoft information protection, Office 365, identity and access, security engineer or security operations exams would be very welcomed.

Special Skills:

·       Strong analytical, problem-solving, critical thinking ability.

·       An eye for detail that will make you question what you see in an audit log.

·       An appetite and passion to always learn new technologies and push yourself to be a better engineer.

·       A security mindset, always thinking "what if an attacker tried this?"

·       Excellent people skills capable of working seamlessly with support teams in the IT department even when under pressure.

Additional Information

Full-time position
Competitive salary and benefits
Remote working with requirement to visit the office in Guildford usually just once per week.

 

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Ergomed is hiring a Remote Director, Statistical Programming

Company Description

Founded in 1997 by a Medical Doctor , Ergomed Plc is dedicated to the development of new drugs to save or improve lives. Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials.  Ergomed provides services to over 100 clients in a range of therapy areas but excels in the provision of services for  complex trials in Rare Diseases, Oncology and Neuroscience.

Job Description

The Manager of Statistical Programming is a key member of the Biometrics leadership team as they will be responsible for the growth, development, and oversight of a team of Statistical Programmers.  

Role and Responsibilities

  • Managing a team of Statistical Programmers by:
    • Ensuring that all team members receive continual support and experience a positive career trajectory
    • Overseeing work to ensure on-time, on-budget, and high-quality output
    • Evaluating the performance of current employees and provideing targeted growth and development
    • Assessing new candidates to support ErgoMed's growing pipeline
  • Supporting Operational Excellence through:
    • Continuous improvement of processes and tools including controlled documents, macros, and other department assets
    • Overseeing projects and team members to ensure best practices are followed and necessary support is provided
    • Participating as a contributor to highly technical, complex, or other key projects
  • Representing Statistical Programming (and as needed, Biometrics) to internal senior leadership and/or to external organizations (e.g., audits, bid defenses, conferences, etc.) regarding topics of performance, quality, goals, and other relevant topics.
  • Supporting Biometrics (and Operations) leadership on topics related to corporate goals, department development, industry trends, and other relevant topics.

Qualifications

The ideal candidate will have:

  • Bachelors degree in Statistics or Biostatistics or related field
  • Minimum 5 years of pharmaceutical area industry experience. Prior CRO experience preferable

  • Experience as a people manager preferred, but not required 

  • In-depth knowledge of statistical data analysis and data management principles, including knowledge of relevant Data Standards (i.e. SDTM/ADaM)

Additional Information

We offer excellent chances to progress and develop. We work on a global basis on interesting projects within rare diseases, oncology, and neurology. This is an ideal position to develop a career in clinical drug development. 

 

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Ergomed is hiring a Remote Senior Director, Biostatistics

Company Description

Founded in 1997 by a Medical Doctor, Ergomed Plc is dedicated to the development of new drugs to save or improve lives. Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials.  Ergomed provides services to over 100 clients in a range of therapy areas but excels in the provision of services for  complex trials in Rare Diseases, Oncology and Neuroscience.

Job Description

POSITION SUMMARY

The Manager, Biostatistics functions as a member of the Biostatistics (and Biometrics) leadership team and manages the day-to-day activities of a team of Biostatisticians. 

You will be responsible for the quality, budget, and timeliness of work within their team including ensuring that all work is performed to follow industry standards and all relevant internal processes.  

The Manager, Biostatistics will be responsible for (but not limited to) the following activities:

  • Manages a team of Biostatisticians overseeing project activity including aspects of quality, budget, and timelines
  • Ensures that all work for relevant studies is resourced appropriately
  • Supports the growth and development of all members of the Biostatistics function
  • Participates in relevant performance management activities including review, development, and problem mitigation
  • Participates in the review and assessment of new team members
  • Develops best practices to achieve Biostatistics department goals

Supports Operational Excellence

  • Acts as a senior reviewer and support for Biostatistics work performed at ErgoMed
  • As needed, leads and/or supports the creation of client deliverables with an emphasis on large, complex, or other high priority opportunities
  • Reviews budgets and supports the general budget and proposal creation process to ensure accurate reflection of customer needs and scope of work
  • Supports the creation of templates, reusable text, or other work products that may support future work by improving quality and/or reducing cost/effort.

** Please note this position can be located in either the UK or Germany - home based or from one of our offices **

Qualifications

The ideal candidate will have:

  • Master’s degree (or Higher) in mathematics, statistics, biostatistics, computer science, or other related disciplines.
  • Extensive experience in Biostatistics, preferably in a CRO or related industry/organization
  • Good organization skills, including attention to detail and multitasking
  • Ability to motivate/coach people - previous people management experience is essential for this position
  • Knowledge of advanced statistical methods (e.g., survival analysis, logistic regression, and mixed models)
  • Advanced literacy (MS Office with focus on MS Word; EndNote reference manager; PDF creator)
  • Experience with the SAS Programming language sufficient to review and validate study related statistical output.

Additional Information

Why Should You Apply?

  • You want  be involved in a wide range of interesting projects and studies
  • You want your achievements and hard work to be recognized
  • You want to work for a growing company where you can progress in your career and where there are opportunities for advancement.
  • You want to work in a company that has a great reputation with its clients and employees, and invests in its relationships with both.

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Ergomed is hiring a Remote Case Processing Manager (Pharmacovigilance)

Company Description

PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative safety services for pharmaceutical, generic and biotechnology companies. Our founders and leaders have an unrivalled reputation in the sector with a network of expert associates across the world.

Job Description

POSITION SUMMARY

  • Manages and mentors Team Leaders for assigned projects
  • Leads the team responsible for ICSR management for a selected project or group of projects as ICSR team lead
  • Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process
  • Assures and exerts of activities leading to effective cooperation with clients in the area of ICSR Management
  • Contributes to achieving company´s goals and objectives
  • Works independently

KEY RESPONSIBILITIES

  • Providing support to other activities undertaken by the project team on behalf of the client and the company
  • Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):
  • Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
  • Performing ICSR follow up
  • AE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
  • Reconciliation (clinical, partners)
  • Personal data protection
  • Product Quality Complaint handling and interaction with Quality Assurance
  • Medical Information interaction
  • MedDRA and WHO coding
  • Database Outputs and Reports (including data for monthly reporting to clients)
  • Workflow & resource management
  • Line Management tasks (periodic appraisals, performing vacation approval, ensuring adequate cover is in place to meet operational requirements for existing and new contracts)
  • Mentoring and training of new and more junior employees within the department
  • Support of PV processes related to the ICSR management within PrimeVigilance and also to clients
  • More senior colleague may perform tasks assigned as per SOP to more junior position
  • Performing activities in the scope of ICSR management unit within agreed extent and timeframe

 

Case Processing Manager responsibilities:

  • Leads the team responsible for ICSR management for a selected project or group of projects as Case Processing Manager:
  • Following are Case Processing Manager responsibilities (including, but not limited to):
  • Leadership and expert advice in the area of ICSR management
  • Line management of the assigned team and subordinated colleagues
  • Training and development of skills
  • Ongoing and periodic appraisal
  • Equal distribution of workload
  • Coordination of activities with Team Leads and other Case Processing Managers, where applicable
  • Project team members allocation based on times spent on ICSR management activities for the given projects, resource management and ICSR workflow management
  • Supervise, train and develop colleagues in the team, as well as provide training to other PrimeVigilance’s employees and clients
  • Support in authoring/development of quality documents in the area of ICSR Management Unit
  • Monitoring and analysing activities entered in ActiTIME by employees within assigned project teams
  • Monitoring the regular entry of data in ActiTIME and, if necessary, requesting entry of incomplete data
  •  Monitoring team utilisation for ongoing projects and proposing productivity target updates to ICSR Operational Lead based on ActiTIME data analysis
  • With regard to the analysis of data from ActiTIME for assigned project teams and in coordination with other Case Processing Managers, propose temporary or permanent allocation of resources to ICSR Operational Lead, all with the aim of maintaining a high level of productivity and utilization
  • Supporting other Case Processing Mangers, ICSR Operational Leads and ICSR Functional Head for requests related to assigned project and team
  • Providing team assignments for new projects or increased scope of work for existing projects, when requested by Directors of Projects or ICSR Operational Leads
  • Reviewing and approving of all Minor CAPAs from assigned project teams
  • Reviewing and addressing any requests from Quality department regarding assigned project teams

Qualifications

Education

Educated to degree standard or appropriate work experience

Experience

Extensive Pharmacovigilance experience including leading a team.

Special Skills

  • Excellent communication (written and verbal) skills
  • Organization skills, including attention to details and multitasking
  • Delegation skills
  • Planning and time management
  • Technical skills
  • Team working

Additional Information

Why Should You Apply?

  • You want  be involved in a wide range of interesting projects and studies
  • You'd like  your  achievements  and hard work to be recognized
  • You want to work for a growing company where there are opportunities for advancement
  • You'd like to work in a company that has a great reputation with its clients and employees.
  • Making a difference to people's lives matters to you

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+30d

Senior Study Start-Up Specialist

ErgomedRaleigh, NC, USA, Remote

Ergomed is hiring a Remote Senior Study Start-Up Specialist

Company Description

Founded in 1997 by a Medical Doctor , Ergomed Plc is dedicated to the development of new drugs to save or improve lives. Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials.  Ergomed provides services to over 100 clients in a range of therapy areas but excels in the provision of services for  complex trials in Rare Diseases, Oncology and Neuroscience.

Job Description

SUMMARY:
Provide Study Start-Up Specialist activities in support of assigned projects including IRB/IEC submissions, informed consent review, essential document collection and review in preparation of site initiation and activation. Provide leadership to junior department and project team members.


DUTIES AND RESPONSIBILITIES:
• Work closely with project teams to ensure efficient start-up processes for assigned projects in accordance with ICH-GCP, relevant Standard Operating Procedures (SOPs) and/or Sponsor-specific requirements.
• May act as Study Start-Up Specialist Lead at project level; may directly interact with customers and sponsors as required. May serve as main point of contact for all project-specific Study Start-Up Specialist activities.
• Forecast site-specific submission/approval timelines based on site specific information and in accordance with Sponsor expectations and ensure they are met; if forecasted timelines are not reached, provide clear rationale for delays and contingency plans to mitigate impact. Anticipate and identify site issues during start-up process and resolve minor to moderate issues independently. Communicate regularly with study team members and escalate complex issues as soon as identified.
• Draft and/or review essential documents and templates for mass distribution to sites, distribute with initial welcome packets and arrange for receipt of essential documents; assist with dissemination of patient recruitment and other study materials and updates to essential documents.
• Collect, review for completeness and compliance, and track essential documents for Study Start-Up Specialist to facilitate efficient site initiation and activation. Investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of information. Prepare study team reports or updates regarding status of essential document collection, review and approval.
• Actively correspond with selected sites for updates regarding essential document completion, Informed Consent Form (ICF) development and Institutional Review Board (IRB)/Independent Ethics Committee (IEC) submissions/approvals.
• Participate in ICF development, review, negotiation and approval processes.
• Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other functional areas on the priority and processing of documents leading to investigational product release, site activation and site initiation.
• Attend project team meetings and training sessions according to project and/or Sponsor requirements.
• Monitor number of hours/tasks available for Study Start-Up Specialist activities per project specifications; escalated discrepancies in a timely manner.
• May serve as main point of contact for Central IRB/IECs and prepare submissions for multicenter trials; facilitate preparation of site submissions to Local IRB/IEC as defined by local requirements. Facilitate and process IRB/IEC Continuing Review or Re-Approvals, Protocol Amendment and update to Investigator Brochure.
• Arrange for and/or review translation of essential documents as required.
• Assist with feasibility and site identification activities as needed.
• Ensure all relevant essential documents are submitted to Trial Master File (TMF) in a timely manner as defined by SOPs and study-specific requirements.
• Assist with mentoring and training of department staff and new-hire

Qualifications

MINIMUM JOB REQUIREMENTS / QUALIFICATIONS:
• Bachelor’s degree (BA/BS) in a science-related field preferred or equivalent combination of education, training and experience.
• Experience working the pharmaceutical, biotechnology or CRO industry and knowledge of clinical trials process required.
• Experience in Study Start-Up Specialist and activation and document collection and review required.


KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
• Excellent oral and written communication skills.
• Excellent interpersonal and organizational skills with strong attention to detail.
• Good customer/client relationship management and proactive problem-solving skills.
• Knowledge of the principles, methods, and procedures of clinical research.
• Good computer skills including MS Word, Excel, PowerPoint, Outlook.
• Experience with ICH/GCP documentation and process preferred.
• Ability to assess, coordinate, and organize/reorganize workload of multiple projects in accordance with project priorities/assignments and timelines with focus on execution.

Additional Information

We offer excellent chances to progress and develop. We work on a global basis on interesting projects within rare diseases, oncology, and neurology. This is an ideal position to continue developing a career in clinical drug development. 

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Ergomed is hiring a Remote Director, Trial Optimization and Delivery, Rare Disease Innovation Center

Company Description

Since its foundation, Ergomed has been dedicated to the development of new drugs to save or improve lives. Operating globally Ergomed has the expertise to manage the most challenging of clinical trials. We provide services to over 100 clients and excel in the provision of services for complex studies.

 

Job Description

The Director, Strategic Feasibility & Optimization, Rare Disease will interact with Rare Disease external partners, executive leadership, business development, and project teams to support the strategy for Rare Disease projects globally.  

Responsibilities include: 

  • Assist with RFP, RFI, Proposal review and response as directed
  • Provides strategic and clinical study feasibility for our Rare Disease Projects and Clients
  • Provides support with managing and tracking Rare Disease Innovation Center external partners and activities
  • Develops processes and solutions to maximize the Rare Disease Innovation Centre functions and activities
  • Monitors the progress of all Rare Disease Activities - Engagements,
  • Request for Proposals, Sales, Rare Disease Innovation Center Solutions, External Partners
  • Attends and presents at Bid Defense Meetings
  • Develops cases studies and reportsSupports SVP and Head Rare Disease Innovation Center as needed on projects and activities

Qualifications

  • Degree educated in Life Sciences or equivalent
  • Global Feasibility experience
  • Experience managing external partners
  • Previous experience in a CRO environment
  • Clinical Operations experience in CNS or Metabolic or Rare Disease a plus
  • Report writing and presentation skills
  • Ability to handle multiple tasks to meet deadlines

Additional Information

All your information will be kept confidential according to EEO guidelines.

Our Offer:

  • Work within a successful, highly – qualified and dynamic team
  • Professional training and career development in a fast-growing healthcare company

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Ergomed is hiring a Remote Budget Developer (contracts and proposals)

Company Description

Ergomed is looking for a Budget Developer to join our dynamic and rapidly growing organization, working within a closeknit proposals and contracts team

Job Description

The Ergomed Budget Developer works in the Proposals & Contracts department of the Business Development group. They are responsible for the production of accurate study budgets in collaboration with internal department leaders, legal, and finance. They support budget development for CRO and PV opportunities/rebids, budget updates until award/contracting, and CRO Change Orders. They are responsible for the management of clinical vendor budgeting, contract budget negotiation, client grid management, and supporting financial reporting.

Qualifications

1-3 Years in the CRO industry working on Budget Development.

Proficient in English, well-organized and works well in a high paced environment

Additional Information

Our Offer:

  • Competitive salary
  • Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
  • Multicultural environment, English as a company language
  • Strong emphasis on personal and professional growth

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Ergomed is hiring a Remote Director, Strategic Feasibility & Optimization, Rare Disease

Company Description

Since its foundation, Ergomed has been dedicated to the development of new drugs to save or improve lives. Operating globally Ergomed has the expertise to manage the most challenging of clinical trials. We provide services to over 100 clients and excel in the provision of services for complex studies.

 

Job Description

The Director, Strategic Feasibility & Optimization, Rare Disease will interact with Rare Disease external partners, executive leadership, business development, and project teams to support the strategy for Rare Disease projects globally.  

Responsibilities include: 

  • Provides strategic and clinical study feasibility for our Rare Disease Projects and Clients
  • Provides support with managing and tracking Rare Disease Innovation Center external partners and activities
  • Develops processes and solutions to maximize the Rare Disease Innovation Centre functions and activities
  • Monitors the progress of all Rare Disease Activities - Engagements,
  • Request for Proposals, Sales, Rare Disease Innovation Center Solutions, External Partners
  • Attends and presents at Bid Defense Meetings
  • Develops cases studies and reports
  • Supports SVP and Head Rare Disease Innovation Center as needed on projects and activities

 

 

Qualifications

  • Degree educated in Life Sciences or equivalent
  • Clinical research experience in Rare Disease
  • Global Feasibility experience
  • Experience managing external partners
  • Previous experience in a CRO environment
  • Report writing and presentation skills
  • Ability to handle multiple tasks to meet deadlines

Additional Information

All your information will be kept confidential according to EEO guidelines.

Our Offer:

  • Work within a successful, highly – qualified and dynamic team
  • Professional training and career development in a fast-growing healthcare company

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Ergomed is hiring a Remote Senior Project Manager - Rare Disease & Oncology

Company Description

Founded in 1997 by Medical Doctors , Ergomed Plc is dedicated to the development of new drugs to save or improve lives. Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials.  Ergomed provides services to over 100 clients in a range of therapy areas but excels in the provision of services for complex trials in Rare Diseases and Oncology.

Job Description

  • Ensure the projects are delivered on time, within budget, and agreed scope, maintaining the appropriate industry, sponsor and Ergomed quality standards
  • Liaise with project team members, provide training where needed and ensure correct allocation to tasks
  • Develop, review and edit of project plans to assure consistency with project goals
  • Organisation and facilitation of project meetings related to study activities (study organization, initiation, execution, closure)
  • Point of contact with Sponsor and Ergomed Senior Management on project status
  • Represent Ergomed at external meetings, providing liaison with scientific/medical experts in other CRO/Sponsor companies and for committee meetings, (e.g.EC/IRB)
  • Develop review and edit of relevant SOPs to assure consistency with Regulatory standards and develop study related training programs to support this.
  • Contribute to bid defence activities

 

Qualifications

 

  • Experience of managing international clinical trials in a CRO environment
  • Knowledge of oncology and rare disease trials 
  • Experience in selecting and managing external service providers
  • Strong analytical, organisational, communication and numeracy skills
  • Minimum 5 years’ experience in CRO Industry.
  • Bachelors Degree in a science related discipline.

 

Additional Information

Why Should You Apply?

  • You want  be involved in a wide range of interesting projects and studies
  • You'd like  your  achievements  and hard work to be recognized
  • You want to work for a growing company where there are opportunities for advancement
  • You'd like to work in a company that has a great reputation with its clients and employees.
  • Making a difference to people's lives matters to you

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+30d

Senior Project Manager - Oncology

ErgomedRaleigh, NC, USA, Remote

Ergomed is hiring a Remote Senior Project Manager - Oncology

Company Description

Founded in 1997 by Medical Doctors, Ergomed Plc is dedicated to the development of new drugs to save or improve lives. Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials.  Ergomed provides services to over 100 clients in a range of therapy areas but excels in the provision of services for  complex trials in Rare Diseases, Oncology and Neuroscience.

Job Description

 

  • Ensure the projects are delivered on time, within budget, and agreed scope, maintaining the appropriate industry, sponsor and Ergomed quality standards
  • Liaise with project team members, provide training where needed and ensure correct allocation to tasks
  • Develop, review and edit of project plans to assure consistency with project goals
  • Organisation and facilitation of project meetings related to study activities (study organization, initiation, execution, closure)
  • Point of contact with Sponsor and Ergomed Senior Management on project status
  • Represent Ergomed at external meetings, providing liaison with scientific/medical experts in other CRO/Sponsor companies and for committee meetings, (e.g.EC/IRB)
  • Develop review and edit of relevant SOPs to assure consistency with Regulatory standards and develop study related training programs to support this.
  • Contribute to bid defence activities

 

Qualifications

  • Experience of managing international clinical trials in a CRO environment
  • Ideally knowledge of oncology trials 
  • Experience in selecting and managing external service providers
  • Strong analytical, organisational, communication and numeracy skills
  • Minimum 5 years’ experience in CRO Industry.
  • Bachelors Degree in a science related discipline.

 

Additional Information

Why Should You Apply?

  • You want  be involved in a wide range of interesting projects and studies
  • You'd like  your  achievements  and hard work to be recognized
  • You want to work for a growing company where there are opportunities for advancement
  • You'd like to work in a company that has a great reputation with its clients and employees.
  • Making a difference to people's lives matters to you

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+30d

Quality Assurance Officer

ErgomedPrague, Czechia, Remote

Ergomed is hiring a Remote Quality Assurance Officer

Company Description

PrimeVigilance, an Ergomed brand , was established  to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding and prevention of adverse effects.

Ergomed Plc is a public company on the London stock exchange with  its HQ in Guildford, UK.  The company boasted 40% growth in its revenues in its last report.  This success is due to the hard work of our highly skilled employees and our subsequent  reputation for excellence with our clients. 

Job Description

The Quality Assurance Officer provides support to the Quality Assurance (QA) team for all audit, inspection and Corrective and Preventative Actions (CAPA) activities, both internally and externally. Support for other QA activities could also be requested. Contributes to achieving company´s goals and objectives.

The Quality Assurance Officer will support all audit activities within PrimeVigilance and will work with the Auditing team and Quality team s to ensure audits are delivered in line with PrimeVigilance and procedures and global regulations.

The Quality Assurance Officer will oversee all activities described, including but not limited to:

Audit Support

  • Supports PrimeVigilance functional teams pre-, during and post-audits by clients or by internal QA function
  • Supports local client audit hosting and inspection support
  • Assist in client specific requests for audit scheduling

Administrative support

  • Support QA in the tracking of audit status and deliverables

CAPA Support Activities

  • Supports in tracking of the client audit CAPAs.
  • Support in the facilitation of CAPA response
  • Input into the global audit CAPA tracker

Other Supportive Responsibilities

  • The Quality Assurance Officer will support the PrimeVigilance Senior Leadership team as needed.
  • Other QA support as needed.

IF LINE MANAGER (optional)

  • Line management tasks (periodic appraisals, performing holiday approval, ensuring adequate cover is in place to meet operational requirements for existing and new contracts)
  • Mentoring and training of new and more junior employees as required.

Qualifications

University degree in Biomedical sciences, Natural sciences or Health Sciences is required: Nursing, Pharmacy or BS/Master’s degree in a scientific discipline, or equivalent advanced degree with experience. Or equivalent industry experience

Essential

  • Previous experience in the pharmaceutical and/or regulated industry in a quality setting – preferably in Pharmaceuticals or Healthcare
  • Thorough understanding of the principles of Quality Assurance
  • Knowledge of national regulations related to Pharmacovigilance and Medical Information
  • Experience of participating in audits and inspections
  • Excellent communication and facilitation skills within a global organisation
  • Proactive and self-motivated

Desirable

  • Familiarity with international regulations is desirable
  • Organization skills, including attention to details and multitasking
  • English - advanced (spoken, written)
  • Advanced literacy (MS Office)

Additional Information

All your information will be kept confidential according to EEO guidelines.

Our Offer:

  • Work within a successful, highly – qualified and dynamic team
  • Professional training and career development in a fast-growing healthcare company

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Ergomed is hiring a Remote Pharmacovigilance Project Manager (Homebased in Europe)

Company Description

PrimeVigilance, an Ergomed brand , was established  to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding and prevention of adverse effects.

Ergomed Plc is a public company on the London stock exchange with  its HQ in Guildford, UK.  The company boasted 40% growth in its revenues in its last report.  This success is due to the hard work of our highly skilled employees and our subsequent  reputation for excellence with our clients. 

Job Description

PrimeVigilance is continuing to expand and is looking for an experienced Pharmacovigilance (PV) Project Manager to join our dynamic, rapidly expanding organisation.

The PV Project Manager will be responsible for leading and managing long term engagements with our clients.

Experienced home based project managers will also be considered.

Key Responsibilities

  • Representing the client's interest with the aim of achieving client´s goals and objectives and the Prime Vigilance’s interest with the aim of keeping the agreed project scope.
  • Preparing project scope and objectives based on the signed agreement between the client and PrimeVigilance.
  • Management of client’s expectations to make sure the client is satisfied with services of PrimeVigilance, and that the work PrimeVigilance delivers meets, or even exceeds, the clients’ expectations.
  • Acting as the primary contact point for project-related matters for both the client and PrimeVigilance staff.
  • Project activities planning.
  • Coordinating the colleagues working on a project.
  • Maintenance of project-specific RAM (Responsibility Assignment Matrix).
  • Assurance, that all PV Division staff is familiar with the client and the project scope.
  • Assurance of training of all team members from relevant quality documents, including project-specific documentation.
  • Having an overview of all tasks to be delivered to the client, including deadlines and interim milestones.
  • Making sure that all the outputs are delivered in high quality and before the final deadline set up by client.
  • Reporting the client and the PrimeVigilance management, e.g., preparation of Monthly reports, serving as basis for invoicing.
  • Preparation of Accounting of Services and invoice, if delegated.
  • Keeping of an oversight on all communication with client.
  • Making sure that quality standards applicable to the respective client are met.
  • Having an overview of all SOPs relevant to the respective client.
  • Monitoring of compliance results and proposing corrective and preventive actions, where necessary. Preparation of Deviation reports.
  • Acting as audit/inspection coordinator, if applicable.
  • Proposing processes improvements.
  • Leading by example.
  • Proper hand-over of all open issues, ongoing project tasks and upcoming milestones and deadlines before his/her absence to project manager deputy.

Qualifications

 

  • Previous experience in Pharmacovigilance activities including; processing and quality review of ICSRs, writing or contributing to aggregate reports, literature screening, reconciliation, and preparation of SOPs
  • Ideally previous experience with invoicing/budgets  
  • Health Care Professional or Life Science Graduate
  • Be comfortable with communicating at senior levels within pharmaceutical organisations
  • Have good leadership qualities including skills in planning, mentoring, meeting facilitation, communication and problem solving.
  • Knowledge of Argus, ARISg, Microsoft Excel, Visio and Project preferred
  • Previous experience within a service provider environment preferred

 

Additional Information

All your information will be kept confidential according to EEO guidelines.

Our Offer:

  • Work within a successful, highly – qualified and dynamic team
  • Professional training and career development in a fast-growing healthcare company

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Ergomed is hiring a Remote Senior Medical Information Associate (French Language)

Company Description

PrimeVigilance is continuing to expand and is looking for a Senior Medical Information Associate with French language to join our dynamic and rapidly growing organization.

Job Description

The role is ideal for a confident and enthusiastic individual with an understanding of Medical Information who is looking to develop or build on their knowledge and gain exposure in assisting in the growth of a medical information department in the service provider industry. Knowledge of pharmacovigilance is also an advantage.

  • To take responsibility for handling medical information enquiries
  • To provide approved responses to medical enquiries from external customers including healthcare professionals and patients as well as assisting the pharmaceutical clients’ internal departments with queries where required. This includes acting as a call handling agent as part of the Medical Information dedicated call center;
  • To prepare responses to enquiries based on research in the literature and collaboration with physicians both internally and with pharmaceutical client internal departments, if applicable;
  • To participate in the out-of-hours provision of medical information for clients who have contracted a 24/7 enquiry handling service

Qualifications

 

  • An undergraduate degree in life sciences or equivalent advanced degree with experience.
  • Customer service experience is an advantage
  • Advanced knowledge of both English and French
  • Advanced knowledge of MS Word and Excel
  • Excellent attention to detail and organizational skills
  • Independent problem solving and decision-making skills
  • Process oriented and critical thinking
  • Responsible approach to work duties

 

Additional Information

Our Offer

  • Competitive salary
  • Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
  • Multicultural environment, English as a company language
  • Strong emphasis on personal and professional growth
  • Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
  • Friendly working environment with several social events per year

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Ergomed is hiring a Remote Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA)- homebased flexibility

Company Description

PrimeVigilance, an Ergomed brand, was established to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects.

Ergomed Plc is a public company on the London stock exchange with its HQ in Guildford, UK. The company boasted 40% growth in its revenues in its last report.

This success is due to the hard work of our highly skilled employees and our subsequent reputation for excellence with our clients. 

Job Description

KEY ACCOUNTABILITIES:

The LCPPV/LCPRA is responsible for supporting with local PV/RA services. They provide franchise liaison between Ergomed Plc/ PrimeVigilance and client on a multiple projects’ program. They also provide strategic/advisory guidance to other members of the RA & PV Network team

LCPPV responsibilities:

  • Primary contact person for local regulatory authority / Pharmacovigilance expert as per local requirements
  • Prompt and effective communication with local regulatory authorities
  • Provision of local regulatory intelligence screening
  • Collection and reporting of locally suspected ADRs or ICSRs (FUs, translations)
  • Local management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues
  • Support audits and Inspections

LCPRA responsibilities:

  •  Contact point for NCA  
  • Assistance with local RA portals (if applicable for the country)
  • Participation on local administrative documents for submission  
  •  Review and linguistic input on local Product Information and Mock-ups  
  • Collecting RA Regulatory Intelligence  
  • Ad hoc local regulatory advice  
  • Attending teleconferences  
  • Reporting RA activities to the Client electronically

 

Local Literature Screening (if applicable)

  • Perform local non-indexed literature screening and screening of Regulatory Authority website/s (if applicable for the Client) for potential Adverse Drug Reactions (ADRs) and safety information regarding Client’s medicinal products and those of the same class
  • Provide English summary/translation of the detected literature articles (for all suspected ADRs and potentially relevant safety information)
  • Provide Local Literature Screening tracker monthly to the Project Manager

LCPQA responsibilities (if applicable)

To handle local tasks such as:

  • Quality complaints (received from HA, distributor, customer)
  •  Deviations (received from HA, distributor, customer)
  •  Quality alerts (received from HA)
  • Suspected falsified products
  • Other quality-related requirements received from the local market (HA, media, distributors, wholesalers, pharmacists, health-care professionals, customers).

 

Qualifications

Qualifications and Experience

  • Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent experience
  • Demonstrated experience within pharmaceutical or CRO industry or Regulatory body
  • Demonstrated experience within LCPPV/LCPRA roles
  • PV training and/or working experience and other educational or professional background as required locally
  • Expert knowledge of ICH GVP and most relevant legislation/ local requirements for territories of competency
  • Knowledge of ICH GCP preferable
  • Proficiency in English, both written and verbal and in local language(s
  • Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint

Special skills

  • Strong planning, strategizing, managing, monitoring, scheduling, problem-solving and critiquing skills 
  • Exceptional written and verbal communication skills to clearly and concisely present information
  • Outstanding interpersonal skills in a fast-paced, deadline oriented, and changing environment
  •  Remarkable attention to detail
  • Ability to exercise sound judgment and make decisions independently

Additional Information

All your information will be kept confidential according to EEO guidelines.

Our Offer:

  • Work within a successful, highly qualified and dynamic team
  • Professional training and career development in a fast-growing healthcare company

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+30d

GCP Auditor

ErgomedWarsaw, Poland, Remote

Ergomed is hiring a Remote GCP Auditor

Company Description

ADAMAS Consulting has been leading the industry for over two decades, conducting audits in all therapeutic areas in over 100 countries. By applying critical thinking to solving compliance issues as pragmatically and efficiently as possible we continuously innovate to meet the challenges of the ever-changing clinical landscape.

Job Description

Responsibilities:

  • Perform GCP quality assurance projects which fall within the job holder’s areas of expertise on behalf of client companies within the pharmaceutical industry
  • Contribute to upskilling of consultants in the conduct of vendor and systems audits
  • Actively participate in the ADAMAS Learning Management System
  • Assist with business development activities
  • Perform other reasonable duties as requested by the job holder’s Line Manager
  • Leading, planning, conducting, documenting and following-up of global GCP audits according to applicable regulations, standards, quality agreements, and guidance documents
  • Maintaining current knowledge of regulations, standards, guidance documents, industry initiatives and trend that impact GCP

Qualifications

Requirements:

  • BSc in Life Science Preferred
  • Experience in conducting and leading internal and external GCP audits for a variety of stakeholders
  • Experience in conducting a range of service provider audits (e.g., full service CRO, biostatistics, data management, phase I)
  • Experience in conducting GCP systems audits
  • Experience in coordinating and managing inspection preparation activities for GCP process inspections both at the sponsor and investigator site
  • Experience in conducting GCP mock inspections to Competent Authority standard considered a significant advantage
  • Expert knowledge of national and international GCP legislation and guidelines
  • Proficient in managing projects and ensuring deliverables are provided on time
  • Ability to identify issues and offer solutions in a pragmatic way
  • Ability to travel up to 40% travel and the ability to conduct remote audits

Additional Information

Our people and the way we work set us apart. We work closely with our clients, providing industry-leading innovation and knowledge to deliver solutions that add genuine value to their business.

We place great worth on development and collaboration so we can best succeed together. When needed we also place great importance on intellectual curiosity and the ability to work autonomously.
 

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Ergomed is hiring a Remote GVP Consultant (PV Auditor)

Company Description

ADAMAS Consulting has been leading the industry for over two decades, conducting audits in all therapeutic areas in over 100 countries. By applying critical thinking to solving compliance issues as pragmatically and efficiently as possible we continuously innovate to meet the challenges of the ever-changing clinical landscape.

Job Description

Responsibilities:

  • Planning, preparation, conduct, reporting, and follow up (including CAPA plans) of various types of Pharmacovigilance (PV) audits according to expected quality and timelines
  • Delivery of consultancy services (e.g., providing advice to clients and developing Standard Operating Procedures (SOPs), Quality Management System (QMS), risk-based audit strategies, and regulatory compliance issues, and preparation and delivery of training material)
  • Maintaining an up-to-date knowledge of international regulatory requirements, guidelines and best practices and actively participating in the ADAMAS’ knowledge-sharing and learning process
  • Assist with business development activities

Qualifications

  • BSc in Life Science or Nursing
  • Significant experience in leading and conducting internal and external PV audits for a variety of stakeholders
  • Expert knowledge of applicable PV regulations and guidance
  • Proficient in managing projects and ensuring deliverables are provided in a timely manner and to high quality standards
  • Ability to identify issues and offer solutions in a pragmatic way
  • Highly professional and self-motivated
  • Ability to travel up to 30%

Additional Information

Our people and the way we work set us apart. We work closely with our clients, providing industry-leading innovation and knowledge to deliver solutions that add genuine value to their business.

We place great worth on development and collaboration so we can best succeed together. When needed we also place great importance on intellectual curiosity and the ability to work autonomously.
 

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Ergomed is hiring a Remote Senior Clinical System Specialist

Company Description

Since its foundation, Ergomed has been dedicated to the development of new drugs to save or improve lives. Operating globally Ergomed has the expertise to manage the most challenging of clinical trials. We provide services to over 100 clients and excel in the provision of services for complex studies.

Due to continued growth, we are seeking a (Senior) Clinical Systems Analyst.

Job Description

The (Senior) Clinical Systems Analyst will be responsible for (but not limited to) the following activities:

  • Support the end-to-end lifecycle of Ergomed's applicable clinical systems
  • Understand business goals to effectively translate business needs into system and process improvements.
  • Serve as first line of contact for triaging all support and service requests for each clinical study.
  • Expert in clinical trial management systems (CTMS), to enable rapid and focused decision-making or issue resolution.
  • Identify process inefficiencies and compliance gaps, participates in process improvement initiatives and drive process implementation.
  • Ensure prompt resolution of system issues, and provides timely and accurate responses to customers, as defined in service level agreements.
  • Track and analyse key systems performance indicators (KPIs) and contribute to analysis to identify root causes for defects.

** This position can be offered in any of our European locations **

Qualifications

The ideal candidate will have:

  • Working experience with Clinical Operations and Information Systems and processes with a preference for experience working with "FLEX" CTMS.
  • Knowledgeable with the processes and principles of programme and customer relationship management, and business analysis.
  • Ability to see and anticipate the interrelationship of systems and procedures within a project and understand their interdependencies.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Our Offer:

  • Work within a successful, highly – qualified and dynamic team
  • Professional training and career development in a fast-growing healthcare company

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+30d

Medical Information Manager

ErgomedRaleigh, NC, USA, Remote

Ergomed is hiring a Remote Medical Information Manager

Company Description

PrimeVigilance, an Ergomed company, was established in 2008 by former Drug Regulators, to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem (WHO definition of pharmacovigilance). Since then, PrimeVigilance has added other services including medical information call centres, and has grown to become one of the global leaders in its field, providing services to over 150 client companies in more than 100 countries. We continue to expand as we strive to become the leading global pharmacovigilance and medical information service provider. Our Mission is a world with safer drugs.

Job Description

The Medical Information Manager assists with management of our medical information department.   

Principle Responsibilities include:

Ensuring the delivery of a high quality MI service, and for maintaining compliance with regulations and company policies and in accordance with any Pharmacovigilance and Medical Information agreements.

Leads, educates, mentors and develops the MI team to ensure their competence and confidence in developing MI skills to become subject matter experts.   

Participates in client audits and inspections

Ensuring compliance with PV regulatory obligations; assist with managing the process for root cause analysis and implementing corrective and preventative actions (CAPA)

      

Qualifications

University degree in Biomedical sciences, Natural sciences or Health Sciences is required: Nursing, Pharmacy or BS/Master degree in a scientific discipline, or equivalent advanced degree with experience.

Prior experience supervising within a Call Center operation, preferably in a Medical Information environment

Experience mentoring, training and line managing

Critical thinking and creative problem solving skills

Relationship building skills

Exellent communication skillls

 

Additional Information

Our Offer

  • Competitive salary
  • Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
  • Multicultural environment, English as a company language
  • Strong emphasis on personal and professional growth
  • Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
  • Friendly working environment with several social events per year

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Ergomed is hiring a Remote GCP Consultant (GCP Auditor)

Company Description

ADAMAS Consulting has been leading the industry for over two decades, conducting audits in all therapeutic areas in over 100 countries. By applying critical thinking to solving compliance issues as pragmatically and efficiently as possible we continuously innovate to meet the challenges of the ever-changing clinical landscape.

Job Description

Our Good Clinical Practice (GCP) team of experts assist our clients in identifying the risks in their systems and processes so they can take decisive action in continuous improvement. Through the use of our extensive experience and knowledge, we help safeguard clinical development programs, bringing life-changing therapies to market faster and safer.

As a GCP Consultant, you will be responsible for planning and conducting GCP audits and clinical Mock Regulatory Inspections for our clients in line with the ADAMAS values in quality, integrity, and excellence.

Responsibilities include:

●     Executing audits based on experience and a comprehensive understanding of all federal regulatory requirements and guidance on Good Clinical Practice (GCP).

●     Performing GCP quality assurance projects which fall within your areas of expertise on behalf of client companies within the pharmaceutical/biotechnology industry

●     Contributing to the upskilling of consultants in the conduct of vendor and systems audits

●     Actively participating in the ADAMAS Learning Management System (LMS)

●     Assisting with business development activities

●     Performing other reasonable duties as requested by the job holder’s Line Manager

 

Qualifications

●       BSc in Life Science Preferred

●       Experience in conducting and leading internal and external GCP audits for a variety of stakeholders

●       Experience in conducting a range of service provider audits (e.g., full-service CRO, biostatistics, data management, phase I)

●       Experience in conducting GCP systems audits

●       Experience in coordinating and managing inspection preparation activities for GCP process inspections both at the sponsor and investigator site

●       Experience in conducting GCP mock inspections to Competent Authority standard considered a significant advantage

●       Expert knowledge of national and international GCP legislation and guidelines

●       Proficient in managing projects and ensuring deliverables are provided on time

●       Ability to identify issues and offer solutions in a pragmatic way

●       Ability to travel up to 40% travel and conduct remote audits

 

Additional Information

Our people and the way we work set us apart. We work closely with our clients, providing industry-leading innovation and knowledge to deliver solutions that add genuine value to their business.

We place great worth on development and collaboration so we can best succeed together. When needed we also place great importance on intellectual curiosity and the ability to work autonomously.
 

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+30d

Senior IT Quality Specialist

ErgomedFrankfurt, Germany, Remote

Ergomed is hiring a Remote Senior IT Quality Specialist

Company Description

Ergomed is a rapidly growing  global clinical research company.  We perform clinical trials  for rare and complex diseases.

The company boasted 40% growth in its revenues in its last report.  This success is due to the hard work of our highly skilled employees and our subsequent  reputation for excellence with our clients. 

Due to continued growth, we are seeking a Computer Systems Validation/IT QA Specialist

Job Description

The CSV / IT Quality Specialist is an exciting and integral role within the company and will act as subject matter expert on IT Quality processes and Computer systems validation to ensure compliance with company CSV policy, Annex 11, GXP, 21 CFR part 11, and Data Integrity guidance. 

The major activities of this role would be:

  • Act as IT QA and CSV SME on a range of IT system implementations, producing validation deliverables across full SDLC lifecycle.
  • Provide support in supplier audits
  • Maintain the IT system inventory.
  • Subject matter expert on IT quality policy and processes.
  • Complete Periodic Reviews for a range of different systems.
  • Perform IT quality risk assessments on IT infrastructure and applications.
  • Produce Monthly quality service metrics report.

Qualifications

  • Previous experience of SDLC, testing, and validation within a GxP environment within the Biotech/Pharmaceutical Industry
  • Desired knowledge of Good Clinical Practice (GCP) and  Good Pharmacovigilance Practice (GvP) applicable regulations and guidance related to computerised systems.
  • Knowledge of 21 CFR Part 11, Annex 11, and GAMP 5. Awareness of ISO9001 and ISO27001.
  • Good technical IT knowledge.
  • Experienced in IT System/Software Development Life Cycle (SDLC), change controls, validation, and quality processes.
  • Ability to coordinate complex tasks within the IT function and business as appropriate, including developing plans, coordinating resources, resolving issues, and maintaining compliance to all relevant standards and methodologies.
  • Good / Strong English language skills (written and spoken)
  • Proven capability in writing documentation
  • A good understanding IT Technologies
  • Awareness/Certification in ITIL processes.
  • Proven communication skills are essential in this role

Additional Information

Our Offer

  • Competitive salary
  • Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
  • Multicultural environment, English as a company language
  • Strong emphasis on personal and professional growth
  • Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
  • Friendly working environment with several social events per year

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