Associate Director, Deputy QPPV, Europe
Revolution Medicines · Munich, Germany +2 more
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Role summary
Revolution Medicines seeks an experienced Associate Director, Deputy QPPV to support EU pharmacovigilance oversight and assume full responsibility for product safety during the QPPV's absence. The role ensures compliance with EU pharmacovigilance legislation and Good Pharmacovigilance Practices across marketed and clinical-stage oncology products.
What they're looking for
- EU QPPV qualification or equivalent pharmacovigilance credentials and experience
- Extensive knowledge of EU pharmacovigilance regulations, GVP guidelines, and local requirements
- Proven experience managing pharmacovigilance systems and PSMF documentation
- Strong regulatory inspection and audit preparation background
- Experience with signal detection, risk management plans, and safety reporting processes
- Ability to manage multiple stakeholders including EMA and national competent authorities
What you'll be doing
- Maintain and oversee the Pharmacovigilance System Master File in collaboration with the QPPV
- Deputize for the EU QPPV during absences, assuming full legal responsibility for product safety oversight
- Track compliance metrics and key performance indicators for case processing and aggregate reporting
- Review and approve Safety Data Exchange Agreements with commercial partners and affiliates
- Support signal detection, risk management plan development, and benefit-risk assessments
Privacy & handoff
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