Pharmacovigilance (PV) Manager

Salary: Full time starting salary is normally in the range £46,735 to £55,755 with potential progression once in post to £62,728

Background

This is an exciting opportunity to join one of the largest academic UK Clinical Research Collaboration (UKCRC) registered clinical trials units in the country. The Cancer Research UK Clinical Trials Unit (CRCTU) is core funded by Cancer Research UK and specialises in running early and late phase cancer clinical trials in adults and children and early phase non-cancer trials, many of which are international. The CRCTU employs around 200 multidisciplinary staff with a portfolio of approximately 90 active trials, many with innovative designs.

Main Duties

We are seeking a Pharmacovigilance (PV) Manager to take a lead on PV and safety reporting within the CRCTU. Activities will include advising on (and where applicable assessing) Serious Adverse Events (SAEs), preparation of development safety update reports (DSURs), and regulatory reporting to the Medicines for Health Regulatory Agency (MHRA) Individual Case Study Report (ICSR) and the European Medicines Agency (EMA) EudraVigilance systems. The post holder will also maintain oversight of safety reporting across the portfolio and identify areas of ineffective working for PV and safety reporting activities and develop approaches to improve operational effectiveness. The successful candidate will be a member of the CRCTU’s senior management team.

Person Specification

The successful candidate will be educated to BSc level in a biomedical or a related sciences subject or hold another relevant qualification and will preferably hold a formal qualification in PV. They will have extensive experience at a senior level, in PV reporting activities for Clinical Trials of Investigational Medicinal Products (CTIMPs) including assessment of SAEs, regulatory reporting to competent authorities both in the UK and internationally, writing and submitting DSURs, and of medical coding using MedDRA. Experience of safety reporting for device trials would be advantageous.

Informal enquiries can be made to Dr Sarah Bowden, email: s.j.bowden@bham.ac.uk 

To download the full job description and details of this position and submit an electronic application online please click on the 'Apply' button above.

Valuing excellence, sustaining investment
We value diversity and inclusion at the University of Birmingham and welcome applications from all sections of the community and are open to discussions around all forms of flexible working.

Closes: 21/04/2025

Advert information