CK Group are recruiting for a Contract Pharmacovigilance Manager to join a company in the pharmaceutical industry at their site based in Hitchin, Hertfordshire on an initial 6-month fixed term contract basis.
The Location: The role is based at our client's site in Hitchin, which is easily commutable, with access via the A1(M)
The Role: The main purpose of the role will be to
- Perform the role of the Project Manager for pharmacovigilance projects
- Provide advice on pharmacovigilancestrategy and requirements for investigational and marketed products
- Assist with establishing clients’ pharmacovigilance systems including preparation and/or review of SOPs, safety management plans and pharmacovigilance data management plans
Further responsibilities will include:
- Preparing, coordinating and reviewing key pharmacovigilance related regulatory documents for both investigational and marketed products, including the DSUR, PSUR, PBRER, EU-RMP, PSMF, SDEA.
- Preparation and/orreviewing of SOPs, working instructions and other working tools
- Maintain oversight of project activities and provide input into invoicing for specified projects
Your Background: To succeed in this role, you will come from a Life Science background with experience in Pharmacovigilance, including case assessment (with emphasis on post marketing work)
- Experience within a CRO environment would be advantageous.
- Good understanding of EU GVP legislation
Entitlement to work in the UK isessential. For more information or to apply for this position, please contact Hendre Moolman on 01438 842 970 or email firstname.lastname@example.org. Please quote reference 50996.