Job Description

The Specialist, Regulatory and PV Network is responsible for providing the strategy based on regulatory requirements and for completing regulatory and PV deliverables based on an established PV and regulatory plan. They also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or consultants in the planning, organizing, and preparing of regulatory deliverables following project, corporate and industry regulatory strategies. 

The Specialist will also act as Local Contact Person for the designated country.

Job Responsibilities

​​Role and Responsibilities​ 

• Under the direction of a senior member of the team, assume leadership and functional representation for projects of low complexity assigned ensuring effective and rapid coordination and management of deliverables striving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates. 

• Provide intelligence on requirements and contribute to the development of the strategy and set up activities (Project Management Plan, joint operating procedures, POAs and core documents). Support identification of issues and corrective actions. 

• Collect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details and monthly reports. 

• Ensure correct training assignment to and training compliance by the LCPs. 

• Promptly identify and escalate risk/potential risk to the project team which may jeopardise deliverables. 

• Provide Clients expertise and guidance at national level. 

• Maintain awareness of allocated tasks and hours and promptly identify and escalate any OoS. 

• Prepare client’s invoices and review/ approve vendors’ project invoices. 

• Provide support to proposal development and input to budgets, provide department representation to BD meetings as required. 

• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery. 

• Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes. 

• Participate in preparation for audits/inspections and provide department representation for assigned projects as required. 

• Track LCPs' key performance indicators and prepare monthly summary reports. 

• Provide feedback on performance of vendors to aid their assessment. 

• Communicate suggestions for changes to departmental/company processes/procedures.   

Qualifications

• Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience
• Previous experience within the pharmaceutical/CRO industry
• PV training and/or working experience and other educational or professional background as required locally
• Fluent in English, both written and verbal
• Candidate must be proficient in the official language of the country in which they are based, as this is essential for local interactions and compliance.
• Good planning and organizational skills
• Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Good attention to detail

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Job Description

The Specialist/Senior Specialist, Study Start Up and Regulatory is responsible for completing study start-up and regulatory deliverables based on an established SSU  RA management plan. They also serve as a liaison between SSU/regulatory project team, authorities, vendors and investigative sites in the planning, organizing, and executing SSU and regulatory deliverables following project, corporate and industry regulatory strategies.

DUTIES AND RESPONSIBILITIES:

• Support the SSU/Regulatory Lead to project site-specific submission/approval timelines 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.

• Prepare, collect, review regulatory information and documents to support submissions to FDA, EMA and national authorities (CTA/INDs, MAAs/NDAs/BLAs, ODDs, PIPs) as well as Ethic Committees/IRBs for initial authorisation and maintenance, in compliance with the applicable regulations.

• Collect, review for completeness and compliance, and track essential documents 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 regulatory/EC 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.

• Support feasibility, site identification and site documents customization (i.e. informed consent document) as needed and closely follow up with investigative sites for updates/resolution.

• Arrange for and/or review translation of essential documents as required.

• Ensure all relevant essential documents are submitted to Trial Master File (TMF) in a timely manner as defined by SOPs and study-specific 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.
Previous experience in Clinical Trial Regulatory submissions.

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.

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Job Description

The role of business development within the organization is to win new Pharmacovigilance business, guide the overall business strategy and input to the board discussions to shape the business as it prepares for sustained growth and expansion. In order to maximize the potential in the business the Director, Business Development will take responsibility for the business development strategy and client retention in an allocated sales territory or with specified accounts.

The Director, Business Development will work closely with the Business Development team and Functional Managers, to cultivate strong, long term relationships with the key decision-makers in life sciences organizations. Therefore, the ability to use scientific rigor and intellect to discuss service solutions with clients and to target new clients is crucial.

Role and Responsibilities

Initiates, coordinates and develops strategic plans and sales strategies within a specified region.

Meets annual sales goals and objectives of a key strategic region.

To manage the team to identify new business sales opportunities, and to work with the internal PrimeVigilance Team to respond appropriately to any enquiry, For example a Request for Information (RFI) or a Request for Proposal (RFP)

Establish and maintain regular contact and an excellent rapport with future and current clients.

Prepare and organize sponsor presentations such as bid defence meetings

Manage the collection of critical information for proposal preparation

To support the team to understand the RFI/RFP process and to provide detailed input

Monitor and track competitor PV activities

Plan and attend major industrial events and tradeshows as budgeted and required

Identify new markets and research new business opportunities, identifies likely sales points within a specified territory or accounts

Coordinate and manage all activities aiming to develop and retain clients

Collects, compiles, analyses, and presents data related to business development in the region and reports to the VP as required

Provide input and to actively support the VP

Encourage open and transparent communication throughout the business development department and the wider organization.

Provide reports as required for senior management and demonstrate leadership in best reporting practices

Qualifications

EDUCATION

A minimum of a Bachelor's degree (or equivalent) and a higher level degree (Master or PhD, MBA) desirable/MBA preferred

EXPERIENCE

·         PV Sales experience consistent with influencing and driving multiple stakeholders towards meeting the customer’s needs.

·         Knowledge of the PV business

·         Computer competency and familiarity with Microsoft Office & CRM systems

·         Excellent communication and interpersonal skills

·        Strong negotiation and analytical skills

··         Good planning, organization and problem-solving abilities.

·         Strong and effective presentation skills; ability to convincingly present features and benefits of service to clients

·         Travel according to the needs of the business development strategy and to company meetings as required

#LI remote

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Job Description

• Training, consultation and support of Study Site Coordinators /Research Nurses on clinical studies
• Providing non-operational site support to ensure progress of clinical study and to ensure that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and the applicable regulatory requirement(s)
• Notifying Study Monitor / Team on any site issues that are detected in contact with the clinical center and are relevant for them
• Establishing and maintaining relationships with Study Site Coordinators and Investigators to optimize performance of clinical study
• Assistance in development of recruitment strategies and tracking of recruitment or patient retention activities at the site

Qualifications

• Bachelor or Master of Science degree or equivalent (preferably in medical field, i.e. medical nurse)
• Experience as a Clinical site manager, Study nurse or study site coordinator
• Excellent organisation skills with attention to detail
• Excellent interpersonal and communication skills
• Good IT skills (MS Word, Excel, Internet tools)

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Job Description

Job Description

The Manager, Regulatory and PV (Network) will assume leadership and functional representation for projects assigned and coordinate the local contact persons responsible for regulatory and pharmacovigilance activities.

The Manager will also act as Local Contact Person for the designated country.

Job Responsibilities

• Assume leadership and functional representation for projects and/or deliverables of medium/high complexity ensuring effective and rapid coordination and management and execution of regulatory tasks, driving the team to meet the agreed targets and to comply with the agreed procedures.
• Develop strategy and manage set up activities (Project Management Plan, joint operating procedures and core documents) ensuring compliance and consistency with department standards. Support team members in preparing project strategy.
• Act as Local Contact Person for the designated country
• Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures. Problem solve and ensure satisfactory resolution of performance issues or delivery failures.
• Provide expert advice to Clients addressing complex queries and changes in local regulations/guidance.
• Set-up and coordinate the network of local contact persons(LCPs)  for RA and PV in assigned projects.
• Ensure correct training assignment to and training compliance by the LCPs.
• Prepare client’s invoices and review/approve vendor’s project invoices
• Provide training, coaching and mentoring to junior members of staff.
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
• Prepare and/or contribute to the Regulatory Newsletter and update regulatory database when new information is available.
• Ensure collection, QC review and timely dissemination of all regulatory intelligence related to departmental deliverables. Support interpretation and impact analysis on legislation.
• Support client qualification activities. Ensure audit readiness and assign team members to participate as departmental representatives for audits/inspections and provide responses to any findings/follow up questions.
• Contribute to the assessment and qualification of new vendors and ensure appropriate training and compliance with company standards. Support ongoing evaluation of existing vendors.
• Assist in securing new business or repeated business by participating to BDMs, developing and reviewing regulatory sections of proposals, regulatory costing and budgets.
• Drive department / company initiatives, act as a change champion and successfully manage implementation of the changes (communication, timing and implementation plan).

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; or relevant previous PV experience
• Strong experience within pharmaceutical or CRO industry or Regulatory body, with demonstrated experience in a leading/project management role
• Proven ability to successfully manage global projects
• Excellent organizational and management skills are essential attributes
• 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
• Excellent ability to manage multiple tasks, set priorities, and adapt to changing work assignments
• Ability to exercise sound judgment and make decisions independently
• Proficiency in English, both written and verbal
• Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint

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Job Description

The Specialist, Regulatory and PV Network is responsible for providing the strategy based on regulatory requirements and for completing regulatory and PV deliverables based on an established PV and regulatory plan. They also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or consultants in the planning, organizing, and preparing of regulatory deliverables following project, corporate and industry regulatory strategies. 

The Specialist will also act as Local Contact Person for the designated country.

Job Responsibilities

​​Role and Responsibilities​ 

• Under the direction of a senior member of the team, assume leadership and functional representation for projects of low complexity assigned ensuring effective and rapid coordination and management of deliverables striving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates. 

• Provide intelligence on requirements and contribute to the development of the strategy and set up activities (Project Management Plan, joint operating procedures, POAs and core documents). Support identification of issues and corrective actions. 

• Collect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details and monthly reports. 

• Ensure correct training assignment to and training compliance by the LCPs. 

• Promptly identify and escalate risk/potential risk to the project team which may jeopardise deliverables. 

• Provide Clients expertise and guidance at national level. 

• Maintain awareness of allocated tasks and hours and promptly identify and escalate any OoS. 

• Prepare client’s invoices and review/ approve vendors’ project invoices. 

• Provide support to proposal development and input to budgets, provide department representation to BD meetings as required. 

• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery. 

• Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes. 

• Participate in preparation for audits/inspections and provide department representation for assigned projects as required. 

• Track LCPs' key performance indicators and prepare monthly summary reports. 

• Provide feedback on performance of vendors to aid their assessment. 

• Communicate suggestions for changes to departmental/company processes/procedures.   

Qualifications

• Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience
• Previous experience within the pharmaceutical/CRO industry
• PV training and/or working experience and other educational or professional background as required locally
• Fluent in English, both written and verbal
• Candidate must be proficient in the official language of the country in which they are based, as this is essential for local interactions and compliance.
• Good planning and organizational skills
• Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Good attention to detail

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Job Description

Job Description

The Medical Reviewer II is responsible for medical review of lCSRs and literature review, writing signal detection reports, supporting writing and or reviewing of aggregate reports (DSURS, PSURS/PBRERs/PADERS) as required by the Company or Client.

For the Client:

• To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. The review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions.
• To act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues
• To review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, literature screening search strategy
• To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings
• To cooperate in the preparation of and provide input in Risk Management Plans
• Supporting the preparation of responses to regulatory authority requests
• Signalling
• Reviewing line listings
• Participating in signal detection activities including meetings, writing signal detection reports if applicable if required, and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation
• Evaluating and categorizing possible signals and proposing a course of action
• Supporting preparation and review of benefit-risk reports

Qualifications

• The PV Physician should be medically qualified as a physician
• Previous experience in pharmacovigilance
• Ability to review different aggregate report types including PBRERs and DSURs
• Expertise in signal detection activities is essential
• Excellent interpersonal skills
• Ability to plan, organise, prioritise and execute multiple tasks
• Ability to work effectively cross-culturally and cross-functionally and value the importance of teamwork
• Communication skills  
• Presentation skills
• English - advanced (spoken, written)
• Advanced literacy (MS Office)

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Job Description

At Ergomed Group, we view graphic design as visual storytelling that engages, informs, and inspires. We seek a skilled Graphic Designer to transform ideas and concepts into compelling visual representations across various media, including print, digital, and social platforms. The ideal candidate will have an eye for detail and a deep understanding of design principles and current software tools, with expertise in all phases of the design process— from conceptualization to the final product. As a marketing team member, you will collaborate across departments to turn written and verbal ideas into compelling, engaging designs.

Objectives of this Role:

• Work on various projects, including B2B marketing materials, web design, presentation decks, social media assets, and more.
• Collaborate with stakeholders to ensure that designs meet business goals, adhere to brand guidelines, and communicate the intended message clearly and effectively.
• Balance multiple projects simultaneously, managing timelines, budgets, and resources to meet deadlines in a fast-paced environment.
• Analyze and optimize design processes to improve the overall creative workflow.
• Maintain an organized database for all design assets, including photos, graphics, and videos.

Responsibilities:

• Collaborate with teams to design materials such as web pages, presentations, various business development collaterals, internal communications, and marketing assets for digital use.
• Interpret strategic direction and translate it into high-quality designs that align with the brand's identity and effectively communicate the intended message.
• Create original design using Adobe Creative Suite (Illustrator, InDesign, Photoshop) and other design tools, considering elements like color, typography, layout, and imagery.
• Oversee project materials' design and uploading process, ensuring they meet the best practices.
• Stay current with design trends and leverage knowledge of historical and emerging markets to create relevant and impactful designs.

Qualifications

Qualifications:

• Proven experience in graphic design, with a strong portfolio focusing on digital media and B2B marketing
• Expertise in design tools such as Adobe Creative Suite (Photoshop, Illustrator, InDesign, etc.)
• Solid understanding of UI/UX design principles and web-based technologies
• Ability to adapt design styles and formats to suit the defined target market
• Strong communication skills and ability to collaborate with cross-functional teams
• A keen eye for detail and a passion for creating visually appealing and functional designs
• English language proficiency

Preferred Qualifications:

• 3+ years of professional graphic design experience, ideally within a creative or marketing agency environment.
• Knowledge of motion graphics or video editing is a plus
• Bachelor’s degree (or equivalent) in graphic design, art, or a related discipline.
• Working knowledge of CSS3, HTML5, and JavaScript.
• Familiarity with WordPress and content management systems (CMS).
• Photography experience and proficiency with photo-editing software.
• Experience designing for Biotech or Life Sciences industries: Preferred but not required.

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Job Description

The Senior Manager of Quality Management is responsible for leading one or more teams within Quality Management in line with global strategic objectives. The Senior Manager of Quality Management collaborates with global operational functions to ensure Pharmacovigilance and Medical Information activities are conducted in compliance with GVP regulations, the International Conference on Harmonization (ICH) and PrimeVigilance requirements. The Senior Manager of Quality Management leads, educates, mentors and develops the Quality Management function to ensure their competence and confidence in developing skills to become subject matter experts.

Role and Responsibilities

• The Senior Manager of Quality Management has a managerial position responsible to ensure that assigned Quality Management System activities are managed in compliance with regulations and company policies and in accordance with any agreements.
• The Senior Manager of Quality Management maintains oversight of one or more departments within the Quality Management function to ensure that the quality of PrimeVigilance’s Pharmacovigilance and Medical Information activities are in compliance with applicable regulatory requirements, and that its clients’ Sponsor and Marketing Authorisation Holder Obligations are fulfilled. This may include but is not limited to the following:
• Deviations, non-conformities and issue management
  • Supporting PrimeVigilance operational departments in assessing, reporting and addressing deviations, non-conformities and issues within timelines mandated by PrimeVigilance procedures
  • Elevating serious and/or systemic issues with appropriate recommendations to Senior Leadership for immediate and long-term resolution
  • Trending deviation, issue and compliance assessment data for discussion and agreement of recommendations for risk mitigation
• Controlled Procedures
  • Maintaining oversight of the status and quality of applicable PrimeVigilance controlled procedures
• Training
  • Maintaining oversight of training compliance
  • Managing training relating to Quality Management responsibilities
• Electronic Quality Management System
  • Oversight of assigned areas of the system and assisting in maintaining the system
  • Providing user administration and support
  • Managing and testing the Business Continuity Plan for the system
• Change management of controlled systems
  • As required reviewing and assessing changes and upgrades to the system
• Audits and Inspections

Supporting audits and inspections of PrimeVigilance as a Subject Matter Expert for the PrimeVigilance Quality Management department.

Qualifications

• Life science graduate, pharmacy, nursing or other healthcare related qualification
• Demonstrated line management experience
• Extensive applicable pharmaceutical and/or biotech pharmacovigilance experience with a solid understanding of GVP-related Quality Management and Assurance
• GxP Knowledge: In-depth knowledge of the applicable GxP regulations and ICH Guidelines.
• Auditing Knowledge: Demonstrates advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
• ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, SQA Registered Quality Assurance Professional or similar recognised professional status, Quality Management Systems Auditor/Lead Auditor (ISO 9001)
• Negotiation Skills: Demonstrates proficiency in negotiation and conflict resolution.
• Pharmacovigilance Development: Understands the phases, processes and techniques used to execute a Pharmacovigilance development program.
• Product Knowledge: Understands the medical/therapeutic impact of products.
• Scientific Knowledge: Possesses the necessary science education and knowledge to manage quality management and assurance oversight
• Communication skills: Must communicate professionally, clearly, concisely and consistently to external and internal customers, both verbally and in writing. Must demonstrate professional presentation skills and deliver informative and balanced presentations and, when applicable, facilitate resolution of differing opinions.
• Project Management: Must demonstrate proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.
• Organizational skills: Must be able to prioritize work effectively to meet timelines.
• Must be able to manage all tasks assigned and effectively deliver all expected deliverables in an organized and a timely manner and proactively communicate changes in pre-established goals and deadlines.

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Job Description

Due to growth Ergomed is recruiting for an experienced CRO Business Development Director to cover the UK and BeNeLux.

Duties and responsibilities

• Initiates, coordinates and develops strategic plans and sales strategies within a specified territory or accounts.
• Develop account strategies & implementation plans and expand through accounts
• Identify new markets and research new business opportunities, identifies likely sales points within a specified territory or accounts
• Collect critical information for proposal preparation and provide detailed input and leadership of the proposal process for each opportunity initiated
• Prepare and organize sponsor presentations
• Facilitate the preparedness of the team in attending any client meetings. For example, Capabilities meetings or Bid Defence Meetings (BDM)
• Coordinate and monitor any budget or contract negotiations, post award of any work, within a specified territory or accounts.
• Interact with operations, keeping track of study status for projects with sponsors and help coordinate change orders when notified of a change of scope by operations.
• Establish and maintain regular contact and an excellent rapport with future and current clients.
• Monitor and track competitor CRO activities
• Plan and attend major industrial events and tradeshows 

Qualifications

• Considerable CRO sales experience with strong negotiation and analytical skills
• An established network of decision makers within Pharmaceutical and Biotechnology companies and a proven track record of identifying and securing profitable service contracts.
• Awareness of trends, government policies and regulations in clinical trials 
• Excellent communication skills and team leadership capabilities consistent with influencing and driving multiple stakeholders towards meeting the customer’s needs.
• Strong and effective presentation skills; ability to convincingly present features and benefits of service to clients
• Excellent organisational, planning and multitasking skills, as well as a predisposition to entrepreneurship, results and customer focus
• Ability to travel according to the needs of the business development strategy 

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Job Description

Some of the daily activities on this position will include working 2 hours per day on the following tasks: 

• Dealing with and solving issues with the cell phone provider. Paying and tracking monthly payments
• Dealing with and discussing the Health and Safety activities with LOT Consult. Maintaining necessary documentation and follow up with LOT if anything is missing or needed.
• If and when necessary, commination and solving any issues with Bulstratd (additional medical insurance for employees)
• Organization, tracking and payments for the annual medical check-ups for employees
• Organization of the Christmas party and any additional meetings for Bg entity when needed
• Completion and maintaining the books necessary according to the requirements of the Safety conditions at work Law
• Completion and maintaining a tracker with all sick leave certificates for SB Accounting
• Organizing the logistic for receiving and sending back the materials in case of new employees or a leaving employee (computer, phone, screens etc)

Qualifications

• Excellent communication skills within a global organization
• Organizational skills, including attention to detail and multitasking
• English advanced – spoken and written (C1)
• CV submitted in English
• At least intermediate level of Excel skills

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Job Description

The Senior Manager of Digital Marketing at Ergomed Group is responsible for developing, executing, and optimizing digital marketing strategies across multiple channels to drive brand awareness, lead generation, and engagement to support commercial growth. The role requires a strategic thinker who can build and lead a team that manages and executes cross-functional initiatives and leverages data to make informed decisions.  A commercial mindset is crucial to this role, so you will be well-versed in interpreting data to improve ROI for stakeholders. You are proactive and energetic in delivering digital marketing activities, and your expertise will include conversion optimization, Marketing automation platforms, (Marketing Cloud) SEO/SEM, and paid performance marketing (Search, PPC, Paid Social).

• Digital Strategy Development: Develop and implement comprehensive digital marketing strategies aligned with business goals and market trends. Lead the implementation of these capabilities, search, conversion rate optimization, and data and analytics to support future business growth.
• Website Management: Oversee functionality and content of our company business units' websites to ensure a seamless user experience and optimal conversion rates.
• Salesforce Integration: Utilize Salesforce (Marketing Cloud) to drive marketing automation, customer segmentation strategies, and lead conversion.
• Email Marketing: Develop and execute email marketing and nurturing campaigns to drive engagement and new opportunities.
• SEO and SEM: Manage SEO initiatives to improve organic search rankings and oversee SEM campaigns to drive targeted traffic and conversions.
• Analytics and Reporting: Monitor digital marketing performance metrics, conduct ROI analysis, and provide actionable insights to optimize campaigns and drive continuous improvement, focusing on optimization
• Budget Management: Manage digital marketing budget effectively, allocate resources efficiently, and optimize spending to achieve maximum ROI.
• Market Analysis: Conduct regular market research and analysis to identify emerging trends and competitive threats and use insights to support digital marketing strategies and tactics

Qualifications

• Experience: 7+ years of progressive experience in digital marketing, focusing on website management, Salesforce CRM, email marketing, and SEO/SEM.
• Leadership: Proven track record of driving cross-functional collaboration and delivering successful digital marketing strategies to support campaigns.
• Technical Skills: Expertise in Salesforce CRM, CMS platforms (e.g., WordPress), marketing automation tools (e.g., Pardot), and SEO/SEM tools (e.g., Google Analytics, SEMrush).
• Analytical Skills: Strong analytical abilities with experience in data-driven decision-making and proficiency in analyzing metrics and KPIs.
• Communication: Excellent verbal and written communication skills, English, with the ability to effectively present ideas, influence stakeholders, and build strong relationships internally and externally.
• Strategic Thinking: Demonstrated ability to think strategically, innovate, and execute digital marketing initiatives and campaigns to drive business growth and achieve measurable results.
• Bachelor’s degree in marketing, Communications, Business Administration, or related field.
• CRO Experience: Preferred but not required.

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Job Description

The Manager, Project Finance is responsible for managing a team of project financial analysts to provide financial and analytical support to the Department Heads and Project Management teams through performance reporting and financial analysis. The Manager will serve as the liaison between Primevigilance's functional groups and Finance, making recommendations for process and profit improvement.

Line management of up to 15 reports based in Croatia is expected.

Qualifications

• Bachelor’s in Finance, Accounting or equivalent education and experience.
• Demonstrated management experience , preferably in project analysis.
• Extensive relevant finance management or accounting experience, project accounting/analysis a plus.
• Pharmaceutical or CRO experience is desirable.

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Job Description

National Travel Required

Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study

Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment and staff to conducting the clinical study throughout the study period.

Trains investigational site staff as necessary

When applicable, supports preparation of regulatory and / or EC submissions

Participates in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance.

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• Extensive on-site monitoring experience in phase 2/3 trials, ideally with experience of complex trials
• Full working proficiency in English
• Ability to plan, multitask and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills
• Ability to travel

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Job Description

The Senior Pharmacovigilance (PV) Physician II is responsible for medical review of ICSRs, writing and reviewing signal detection reports, writing and/or reviewing aggregate reports (DSURS, PSURS/PBRERs/PADERS, ACOs, responses to regulatory authority requests), writing and/or reviewing riskmanagement reports (RMPs) and mentoring junior PV Physicians. The Senior PV Physician II is also expected to support the QPPV in medical aspects and safety issues as may be required by Company or Client.

For the Client :-

• To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports for medical/causality assessment. Review includes coding, assessment of seriousness, listedness/expectedness and Company causality, as well as writing of Company comment, follow-up questions and Analysis of Similar Events, when required. Including completion of all required supporting documentation such as trackers.

• To complete the adverse event tracker for all ICSRs reports

• To act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues

• To review and approve literature screening search strategy

• To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings

• To cooperate in the preparation of and provide input in Risk Management Plans

• Supporting/to lead the preparation of responses to regulatory authority requests

• Can act as EEA QPPV and/or Deputy for up to 2 clients if required.

• To review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, ACOs or Annual Safety Reports.

• To act as Company Lead in a specific pharmacovigilance area requiring medical input (e.g. for preparation of reference safety information – Company Core Data Sheet)

• Actively participate in the Drug Safety Review Committee - signal detection and risk evaluation process for Client company medicinal products in the product's life cycle.

Serves on Client’s advisory and scientific committees.

Signalling

Reviewing line listings

Participating in signal detection activities including meetings, reviewing of signal detection reports, and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation

Evaluating and categorizing possible signals

Proposing a course of action whenever a possible signal is identified

Supporting preparation and review of benefit-risk reports

Supporting PV Project Managers in the planning of signalling schedule and resources 

Supporting PV Project Managers in the preparation of project-specific working instructions regarding signalling

Overseeing the quality of signal detection activities and providing quality and compliance metrics to the Quality Department

For the Company 

To support the preparation of PV procedures

To provide training and mentoring of junior PV Physicians

To provide medical advice and input to project teams on daily basis

Training, mentoring and managing junior PV Physicians

Continuously working on the development of the procedures on the company level 

Preparing or contributing to the preparation of signalling related company procedures

The Senior PV Physician will support the Director of Projects, as well as the QPPV, on a day to day basis as needed

Supporting the Medical Director in training and mentoring on signalling activities

Qualifications

The PV Physician should be medically qualified as a physician with demonstrated experience in PharmacoVigilance and working in a clinical setting.

Endocrinology experience is required.

Excellent interpersonal skills

Ability to plan, organise, prioritise and execute multiple tasks

Ability to work effectively cross culturally and cross functionally and value the importance of teamwork

Communication skills

Presentation skills

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Job Description

National Travel Required

Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study

Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment and staff to conducting the clinical study throughout the study period.

Trains investigational site staff as necessary

When applicable, supports preparation of regulatory and / or EC submissions

Participates in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance.

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• Extensive on-site monitoring experience in phase 2/3 trials, ideally with experience of complex trials
• Full working proficiency in English
• Ability to plan, multitask and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills
• Ability to travel

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Job Description

Ergomed is looking for a Regulatory Affairs professionals with in-depth experience in managing global complex clinical studies.

Opportunities are open to any geographical location; however, candidates will be required to possess excellent written and communication skills in English as well as good understanding of clinical trials environment/ICH GCP.

Main responsibilities for the role are:

• Assume leadership and functional representation for projects and/or deliverables of medium/high complexity ensuring effective and rapid coordination and management and execution of SSU/regulatory tasks, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates. 

• Develop strategy and manage set up activities (SSU RA Management Plan, procedures and core documents) ensuring compliance and consistency with department standards. Support team members in preparing project strategy, identifying issue and providing resolution. 

• Author/contribute towards the preparation and/or review of complex technical/scientific/legal documentation. 

• Ensure preparation, collection, review of regulatory information and documents to support submissions to FDA, EMA and national authorities (CTA/INDs, MAAs/NDAs/BLAs, ODDs, PIPs) as well as Ethic Committees/IRBs for initial authorisation and maintenance, in compliance with the applicable regulations. 

• Provide expert advice to Clients addressing complex regulatory queries ensuring consistent and high-quality advice across all regions. 

• Ensure that all communications with Regulatory Authorities and Ethics Committees/IRBs are carefully tailored to the specific requirements and tale place only when essential guidance cannot be obtained through other available resources. 

• Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS. 

• Assist in securing new business or repeated business by participating to BDMs, developing and reviewing regulatory sections of proposals, regulatory costing and budgets.  

• Provide training, coaching and mentoring to junior members of staff. 

Qualifications

• Bachelor's Degree in Chemistry, Life Sciences or Medicine

• Minimum 3 years within CRO industry 

• Proven ability to successfully manage global projects 

• Expert knowledge of ICH GCP and/or GVP and comprehensive understanding of relevant legislation/ regulatory requirements globally 

• Very good written and verbal communication skills to clearly and concisely present information

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Job Description

The Specialist/Senior Specialist, Study Start Up and Regulatory is responsible for completing study start-up and regulatory deliverables based on an established SSU  RA management plan. They also serve as a liaison between SSU/regulatory project team, authorities, vendors and investigative sites in the planning, organizing, and executing SSU and regulatory deliverables following project, corporate and industry regulatory strategies.

DUTIES AND RESPONSIBILITIES:

• Support the SSU/Regulatory Lead to project site-specific submission/approval timelines 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.

• Prepare, collect, review regulatory information and documents to support submissions to FDA, EMA and national authorities (CTA/INDs, MAAs/NDAs/BLAs, ODDs, PIPs) as well as Ethic Committees/IRBs for initial authorisation and maintenance, in compliance with the applicable regulations.

• Collect, review for completeness and compliance, and track essential documents 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 regulatory/EC 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.

• Support feasibility, site identification and site documents customization (i.e. informed consent document) as needed and closely follow up with investigative sites for updates/resolution.

• Arrange for and/or review translation of essential documents as required.

• Ensure all relevant essential documents are submitted to Trial Master File (TMF) in a timely manner as defined by SOPs and study-specific 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.
Previous experience in Clinical Trial Regulatory submissions.

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.

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Job Description

The EU QPPV is responsible for:

• The establishment and maintenance of a system which ensures that information about all suspected adverse reactions which are reported to the personnel of the Company, and to medical representatives, is collected and collated in order to be accessible at least at one point within the Community;
• Ensuring that any request from the CAs for the provision of additional information necessary for the evaluation of the benefits and risks afforded by a medicinal product is answered fully and promptly;
• Provision to the CAs, of any other information relevant to the evaluation of the benefits and risks afforded by a medicinal product, including appropriate information on planned post-authorisation safety studies.
• Being continuously available to CAs in Member States and the Agency and the MAH, ensuring adequate back-up procedures are in place.
• Having an oversight of the safety aspects of the company’s medicinal products including an overview of medicinal product safety profiles, any emerging safety concerns, any conditions or obligations adopted as part of the marketing authorisations and other commitments relating to safety or the safe use of the products and other relevant finding raised from studies/programmes conducted by the Company.

Qualifications

• Life-science education background Medicine (human or veterinary) or Pharmacy preferred 
• Solid knowledge of PV system operations and function
• Strong knowledge of Global Regulations, standards and best practices regarding safety processing and reporting, safety surveillance and pharmaceutical industry compliance activities in post-marketing
• Strong operational and managerial skills as demonstrated by leading previous projects or functions
• Strong experience in a PV role, profound experience as QPPV
• Strong oral and written English communication skills

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Job Description

Provides leadership to the global medical function including medical monitoring. Contributes to the ongoing development of the Department and contributes to the business plan at both the tactical and strategic levels. Directly and through subordinate staff, ensures the successful management of medical advisory and medical monitoring projects in compliance with federal regulations, ICH Guidelines, Good Clinical Practices (GCPs) and the Company’s Standard Operating Procedures (SOPs). Additionally, this position involves cross-functional communications, strategic planning, and participation in clients’ strategic decision-making, physician review, medical monitoring and critical interactions with scientific advisors.

The Senior Medical Director will assist the Head of Medical Affairs in educating, mentoring and developing Ergomed physicians to ensure their competence and confidence in developing their skills to become subject matter experts in medical monitoring. The role requires active monitoring of costs and project deliverables and interaction with the project managers, project directors and the Head of Medical Affairs. Additionally, the role must include the review and implementation of efficiency strategies whilst maintaining the highest quality of work.

Interact with executive leadership, customers, business development, and project teams to drive the medical strategy globally.

CORE RESPONSIBILITIES

• Provides all levels of medical monitoring activities including patient safety surveillance and integrity
• Included in multi-cross-functional support to the project team in conducting clinical trials
• Could act as the main point of contact with the sponsor as a medical representative
• Coordination and delivery of trainings, supervision, and oversight of Medical Monitors
• Main point of contact and escalation for Medical Monitors
• Participation in the development and revision of Medical Monitoring SOPs
• Assists with the assignment, transitioning, and assimilation of individuals to work as Medical Advisors, Medical Monitors and Study Physicians on projects
• Interacts with other departments to ensure the required quality of service is provided to a sponsor
• Providing project status reports and metrics to the VP of Global Medical Affairs during regular group meetings, in order to optimize performance (with particular reference to the amount of data, timelines, identifying issues and resolution involved)
• Keeping up to date with current and scientific knowledge in their area of expertise in order to provide high efficiency
• Business development support, proposal budget approval, out of scope approval
• Overseeing and managing a group of medical monitors/SP/medical directors
• Responsible for personnel training to meet job description requirements; responsible for personnel career development in the function

Qualifications

• Medical Doctor degree.
• Additional board certification and/or medical specialty preferred
• Active medical licenses are preferable but not mandatory.
• Extensive experience in clinical research in medical monitoring
• Strong team management background at the global level
• Expertise and extensive clinical research experience
• Experience in corporate leadership involvement and strategic contribution
• Business development experience, including review of proposals, budgets, and bid defense meeting participation required
• Proven, efficient medical communication
• Highly organized, with strong interpersonal, presentational, and documentation skills
• Proven efficiency in timely delivery
• Self-motivated, able to work independently, as well as in multi-disciplinary teams, and with the intellectual flexibility to continually develop and learn new skills
• In-depth knowledge of medical terminology and of GCP, ICH guidelines relevant to global drug safety and drug development process and regulations
• Good decision-making and problem resolution based on all relevant information.
• Strategic thinking, recognizing key issues and providing practical solutions
• Ability to work effectively in an environment characterized by tight timelines and changing priorities.
• Excellent Leadership skills
• Strong coaching and mentoring skills; ability to develop and manage staff performance
• Eagerness to engage in new business contacts and grow Ergomed’s business/client base

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