Job Description
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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