Senior Manager, Pharmacovigilance Quality Assurance

Description

Responsible for the development and maintenance of excellence in Pharmacovigilance QA (PVQA) activities supporting the PV system and Quality Assurance. The Manager, PVQA provides support in ensuring Astellas processes comply with national and international requirements for the pharmacovigilance function and the collection and system reporting of safety information.

This activity comprises both auditing as directed, and consultancy activities. This role develops and manages a subset of the quality system and operations across region. As QA Expert, provides QA consultancy (identifying risk, leading continuous improvement) services to the organization for the Pharmacovigilance and related functions. This role will coordinate the preparation, the conduct and the follow‑up of Regulatory Inspections as directed.

Essential Job Duties

• Execution of regional, cross‑regional and/or global multiple audit programs. This includes the planni...