Senior Director, Qualified Person For Pharmacovigilance, Europe

Revolution Medicines

Remote
Remote
Eu-qppv responsibilities
Pharmacovigilance system oversight
Regulatory compliance and gvp
Revolution Medicines is seeking a Senior Director, Qualified Person for Pharmacovigilance (EU-QPPV) to ensure compliance with pharmacovigilance regulations in Europe while overseeing the company's global PV system. The ideal candidate will possess extensive experience in pharmacovigilance, strong leadership skills, and a deep understanding of regulatory requirements

Job Summary

  • The EU-QPPV is legally accountable for the establishment, maintenance, and oversight of the Marketing Authorization Holder’s (MAH) global PV system and acts as the primary point of contact for the EMA and National Competent Authorities.
  • This role ensures compliance with pharmacovigilance obligations under EU regulations and Good Pharmacovigilance Practices (GVP), maintaining oversight of the safety profiles of medicinal products.
  • The successful candidate will have innate leadership and organization skills, technical expertise, and prior experience as an EU-QPPV, joining the GPS management team.

Matching Summary

Match Score: 85

Revolution Medicines is seeking a Senior Director, Qualified Person for Pharmacovigilance (EU-QPPV) to ensure compliance with pharmacovigilance regulations in Europe while overseeing the company's global PV system. The ideal candidate will possess extensive experience in pharmacovigilance, strong leadership skills, and a deep understanding of regulatory requirements.

Skills & Requirements

Must-have

  • EU-QPPV responsibilities
  • Pharmacovigilance system oversight
  • Regulatory compliance and GVP
  • PSMF establishment and maintenance
  • EMA and NCA contact point
  • Benefit-risk evaluation of products

Nice-to-have

  • Strategic leadership
  • Cross-functional collaboration
  • Vendor management skills
  • Inspection readiness management
  • Culture of safety and vigilance

Key Requirements

  • 12+ years of experience
  • Advanced degree in Life Sciences, Pharmacy, Medicine, or related field
  • Medical degree strongly preferred
  • Registered with the EMA
  • Prior experience as an EU-QPPV

Work Rights

Not specified

Tailored Resume

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