Pharmacovigilance Associate Director, Clinical

2 weeks ago


Welwyn Garden City, United Kingdom Hays Specialist Recruitment Limited Full time

Pharmacovigilance, Associate Director, Clinical Safety - Global Pharma - 12-month contract -OUTSIDE IR35*
My client is a large Global Pharmaceutical company, and they have a position available for an Associate Director, Pharmacovigilance Clinical Safety Science to join their team for an initial 12-month contract. This role is remote with the occasional need tobe present in the office.
OUTSIDE IR35

**Responsibilities**:

- Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas. Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context(e.g., disease under study, safety profile of competitors, mechanism of action)
- Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e., DSUR, PBRER) - Responsible for signal detection and management activities including, but not limited to STARmaintenance, ISMP maintenance. Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests
- Contribute to the development of the product safety strategy and provide drug safety input into the Clinical Development strategy
- Contributing to risk management activities including preparation and maintenance of CCDS, labelling document maintenance (including the IB), risk communications, RMP, REMS
- Contributing to study management from a safety perspective through SMT/PET activities and document review and maintenance across the development continuum (early phase to post marketing studies), including PASS
- Responsible for the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB
- Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable - In partnership with the SSL, support presentation of important safety issues to the Drug Safety Committee (DSC), DevelopmentReview Committee (DRC) and other internal and external review and governance committees as needed.
- Author or contribute to scientific publications (abstracts, posters, papers) for scientific meetings/journals



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