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.
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)
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
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