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Drug Safety and Pharmacovigilance ensures that products are safe to use. Learn all about working in Drug Safety & Pharmacovigilance.
In Drug Safety and Pharmacovigilance (PV) work, you are contributing to the safety of medicines by taking responsibility for the administrative side of monitoring/reporting adverse events (AEs) and side effects. There are many regulations in this area which are of vital importance and these are overseen by various organisations such as EMA, ethics committees and Drug Safety Management Boards. A PV professional plays a key role in implementing the regulations and also in training clinical study teams and sales teams. Typical jobs include Drug Safety Officer (DSO), Patient Safety Specialist or Pharmacovigilance Associate (PVA).
Working in Drug Safety and Pharmacovigilance your focus is on the safety of medicines, whether they are already on the market or still being developed. Risks and benefits are assessed to ensure that products are safe to use, and possible risks are detected and evaluated. In particular, notifications of Adverse Effects (AEs) and side effects reported by healthcare professionals and patients, as well as cases from clinical studies, must be investigated and managed in accordance with the current Regulations and reported to the relevant authorities.
Your pharmacovigilance career might start as a Drug Safety Physician (PV), Drug Safety Associate, Drug Safety Officer or Pharmacovigilance Officer. With the right background and experience such as an understanding of ICH-GCP and medical coding, you could move on to a Drug Safety Manager or Pharmacovigilance Manager role. If you have strong writing skills you could also consider becoming a Drug Safety Medical Writer, responsible for PSURs (Periodic Safety Update Reports), DSURs (Development Safety Update Reports) and RMPs (Risk Management Plans).
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