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Pharmacovigilance Manager

Hertfordshire   •  Contract/Temporary, Full time

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 pharmacovigilance strategy 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/or reviewing 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 is essential. Please quote reference 50996.

You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Hendre Moolman
  • Phone: 01438 743 047
  • Reference: 50996
  • Posted: 25th June 2021
  • Expires: 23rd July 2021

CK Group

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