Head of Pharmacovigilance
- Employer
- Barrington James
- Location
- Denmark (DK)
- Salary
- Competitive
- Start date
- 1 Oct 2020
- Closing date
- 31 Oct 2020
View more
- Discipline
- Clinical Research, Pharmacovigilance
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Senior Management
Job Details
Head of Pharmacovigilance
I am currently partnered with a growing Biotech with an exceptional pipeline, with one product currently on the market and one under registration and a full clinical pipeline, it is a fantastic opportunity to join this business during a period of real growth and development.
The Head of Pharmacovigilance will be tasked with helping the business;
- Develop and execute the safety surveillance strategy and activities for the projects assigned
- Provide drug safety expertise and support to project teams, including preparation of all relevant documents for regulatory submissions
- Execute the signal detection activities, to support the evaluation and decisions of the business Safety Committee
- Prepare the periodic safety reports
- Prepare the Risk Management Plan (RMP) and/or Risk Evaluation and Minimization Strategies (REMS) documents
You will have,
- An MD degree
- Extensive hands-on work experience with drug development in general and in particular with drug safety/pharmacovigilance processes applied in safety surveillance (safety analysis, signal detection and management, DSUR/PSUR, RMP/REMS, internal safety committees, communication with regulatory authorities) Minimum 7 years
- Solid understanding of the PV (EU and FDA) requirements
- Extensive experience within clinical safety and submissions alongside post marketing experience
Please reach out for a confidential discussion.
Company
We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.
Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.
- Website
- https://barringtonjames.com/
- Telephone
- 01293 776644
- Location
-
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB
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