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Senior Director Pharmacovigilance

Meet
Sonoma, CA Full Time
POSTED ON 2/13/2025
AVAILABLE BEFORE 5/12/2025

Senior Director of Pharmacovigilance (PV) – Summary :

Company Overview :

  • Clinical-stage biopharmaceutical company focused on rare diseases.
  • Located in the San Francisco Bay Area, CA.

Key Responsibilities :

  • Evaluate and assess adverse event (AE) reports for safety issues.
  • Manage PV vendors and ensure compliance.
  • Act as Subject Matter Expert (SME) for Individual Case Safety Report (ICSR) processing.
  • Ensure AE reporting complies with global regulations (FDA, EMA, ICH).
  • Update and create SOPs; lead process improvement initiatives.
  • Collaborate with departments and partners on drug safety data exchange.
  • Lead training on AE and product complaints for internal teams and vendors.

    • Qualifications :

  • Education : Bachelor’s in science / health-related field; advanced degrees are a plus.
  • Experience : 10 years in Pharmacovigilance, Drug Safety, or Risk Management.
  • Knowledge : Strong understanding of global PV regulations (e.g., US CFR, EMA, ICH).
  • Technical Skills : Proficiency with safety databases (e.g., Oracle Argus, ArisGlobal).
  • Communication : Strong cross-functional collaboration, leadership, and interpersonal skills.

    • Ideal Candidate :

  • Extensive experience in PV, with expertise in global regulations and safety databases.
  • Strong leadership and ability to drive process improvements.

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