Associate Pharmacovigilance Director
CK Group are recruiting for an Associate Pharmacovigilance Director to join a global bio-pharmaceutical company at their site based in Welwyn Garden City, Hertfordshire on an initial 9-month contract.
The Role: Your main duties will be:
- Responsibility for individual and aggregate case reporting review activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER).
- Contributing to risk management review activities including preparation and maintenance of CCDS, labelling document maintenance (including the IB), risk communications, RMP, REMS.
- Responsibility for signal detection and management activities.
Further responsibilities will include:
- Contributing to the development of the product safety strategy and provide drug safety input into the Clinical Development strategy.
- Contributing to study management from a safety perspective through SMT/PET activities and document review and maintenance across the development continuum.- Authoring or contributing to scientific publications (abstracts, posters, papers) for scientific meetings/journals.
- The ideal candidate for this role will have a Life Science degree with considerable Pharmacovigilance experience.
- Previous experience writing aggregate reports, RMPs, some study experience, and signal detection experience is required.
Apply: For more information or to apply for this Associate Pharmacovigilance Director position, please contact Hendre Moolman on 01246 457733 or email firstname.lastname@example.org, quoting job ref 48423.
It is essential that applicants hold entitlement to work in the UK.