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Pharmacovigilance

pharmacovigilance physician

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 PlansComplete (DSURs), case narratives and any other safety medical documentation, contributing to high quality standard documents within the organizationAlso 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 agenciespreparing 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

reading

Whether you are a sports fan, love a good comedy club or just want a night out with friends, Reading has something for you.

There's great shopping at the Oracle, plenty of green spaces to relax in and a huge range of cuisine from around the world. 

Reading is packed with a range of pubs, bars and clubs, so you can have a drink with your friends, watch an open mic night or hit the dance floor. Reading Festival is one of the best-known music festivals in the UK, with over 87,000 fans flocking to see some of the biggest names in music.

You can also experience the thrill of a live football or rugby match at the Madejski Stadium, which is close to the town centre. The venue, which seats over 24,000 people, is home to Reading FC and London Irish Rugby Club. 

It is ranked the UK's top economic area for economic succuss and wellbeing, according to factors such as employment, health, income and skills. 

There are excellent transport links to London so getting there is easy and simple.