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Serve as a strong partner with Expertise Areas (EAs) in the enhancement of the global pharmacovigilance system through PV quality audits, risk‑based quality oversight, and continuous improvement of PV processes.
Partner and support EAs in ensuring conduct of non-interventional, observational, and post-marketing surveillance (PMS) meet regulatory requirements and expectations considering Good Pharmacoepidemiology Practice (GPP) and Good Post-marketing Study Practice (GPSP)
Support cross GxP QA activities requiring PV and PMS expertise.
Lead and execute global PV quality audits for licensing partners, external PV vendors, internal functions, affiliates, and other applicable service providers in a post‑marketing environment.
Determine, evaluate and investigate Quality Events. Determine adequacy of root cause analyses and CAPAs. Applies risk-based thinking in determining required actions.
Effectively communicate and escalate critical matters to management.
Own and drive the Global PV Strategic Audit Program, including development of risk‑based PV audit strategy, maintenance of the PV audit universe and risk tools, and creation of global PV audit plans and schedules.
Determine, evaluate and investigate PV Quality Events. Own and drive root cause analysis, CAPA development, implementation, and effectiveness checks for PV audits and vendor oversight activities.
Effectively communicate and escalate critical matters to management.
Support the Global Strategic Audit Program - contribute to risk-based audit strategy and maintain and enhance PV audit universe, risk tools and develop PV audit schedule.
Own and execute PVQA contributions to the PV System Master File (PSMF), including compiling, maintaining, and providing audit, CAPA, and supplier quality information to ensure comprehensive and accurate PSMF content
Develop and maintain processes and tools to support quality audit execution and outcomes.
Act as the primary operational PVQA owner and QA contact for global PV, PMS, and PV‑related vendors, including audit planning and execution, CAPA management, and ongoing vendor quality oversight.
Develop and report GVP QA metrics and dashboards to support quality oversight.
Develop and maintain GVP QA Training Plan; conduct PV and PMS training sessions for QA and EAs.
Lead or contribute to Quality or PV and PMS initiatives. Identify and propose process improvement opportunities and solutions.
Other assignments as directed.
Senior Manager, Quality Assurance (PVQA)
Amsterdam, NL +1 more…Posted 3 days ago