Key responsibilities: A Pharmacovigilance Physician is accountable forseveral operational and strategic responsibilities involved with the drug safety profile during development and when approved and marketed. Responsibilities include: Assessing AE events reported in clinical trials.Contributing to safety surveillance strategy and signal detection for individual assets, tracking and evaluating potential issues, including Investigator Sponsored Studies (ISS).Contributing to the development and updating of the Asset Safety Plans, Safety Management Plans, and Safety Study Specific Plans. Complete (DSURs), case narratives and any other safety medical documentation, contributing to high quality standard documents within the organization. Also a Pharmacovigilance Physician may be involved in external engagements depending on the seniority of the position, this will include contributing to medical and safety requests from regulatory agencies, preparing for audits and reviews and liaising with KOLs/ other experts in their field.In smaller organisations, where the role is more autonomous and spans outside of operational data management there may be more involvement with reviewing and interpreting scientific and clinical literature and competitor development information as well as being involved in review processes of essential documents (e.g. IBs, protocols, eCRFs, medical monitoring plans, PILs, informed consents).
Previous roles/experience would include:Pharmacovigilance Physician, Drug Safety Physician, Local Safety Officer, Clinical Research Physician
Usually reports into:Pharmacovigilance Medical Director, Safety Lead, Associate Director Pharmacovigilance, CMO, CSO, EU QPPV
Sits within this team:QPPV, Deputy QPPV, Pharmacovigilance Physician, Drug Safety Physician, Associate Director – Pharmacovigilance, Safety Lead, Local Safety Officer, Drug Safety Associate, Drug Safety Officer, Pharmacovigilance Manager
Qualifications:Medical Degree, MD, MBBS, MBChB, GMC Registration (UK).
Salary band:£50,000 - £100,000 Basic Salary, Bonus, Pension, Private Medical Care, Dental Care