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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