Head of Pharmacovigilance
Well-funded pharmaceutical company that specializes in gene therapies is looking for a head of Pharmacovigilance in Philadelphia, PA.
He/she will be responsible for ensuring that pharmacovigilance systems and processes are in place for the evaluation and reporting of safety information, and other responses, to meet applicable global regulatory requirements for all products from development through post-marketing. The Head of Pharmacovigilance will help to shape the strategy and direction of the global drug safety function to meet the organizational needs and provide influence for overall R&D strategy.
- Provide oversight for the timely preparation of annual IND reports and aggregate safety reports, including PSURs, PBRERs, PADERs, and PBRERs.
- Liaise effectively with other R&D leaders to ensure the smooth flow of safety data and prioritization of safety-related activities.
- Lead all aspects of global drug safety activities and ensure that provision of a clearly defined safety strategy in the context of delivering the risk-benefit profile is established and communicated.
- Conceptualize and implement best-in-class global systems for the collection, collation, evaluation and distribution of safety reports, preparation and submission of aggregate reports, data management, signal detection and risk management.
- MD Degree required
- 1 At least 10 years of experience in drug safety (both pre- and post-marketing) in a pharmaceutical or biotechnology company or CRO including at least 5 years of experience in a leadership role with responsibility for functional processes, systems and talent management
Lucrative position call Ashley Fiorelli at 617-844-1439 or email at firstname.lastname@example.org