Director, Pharmacovigilance
$280,000–$350,000 year
RemoteUnited States
Job Summary
Oversee receipt, processing, medical review, and regulatory submission of Individual Case Safety Reports, including serious adverse events and SUSARs. Ensure timely preparation and submission of aggregate safety reports like DSURs and PSURs, while leading expedited global reporting to health authorities. Establish and lead a formal signal detection process, conduct benefit-risk assessments, and develop risk minimization measures. Partner with Clinical Operations, Regulatory Affairs, and Data Management to integrate safety considerations throughout the drug development lifecycle. Serve as the primary PV point of contact for health authority interactions and collaborate with Data Safety Monitoring Boards. Manage PV agreements with partners and conduct oversight audits of vendor-generated safety reports. Foster a culture of patient safety and manage the PV department budget.
Required Qualifications
- M.D.
- Minimum 5-8 years of pharmacovigilance experience in the biopharmaceutical industry
- At least 1 years in a leadership or director-level role
- Demonstrated expertise in global PV regulations and guidelines (FDA 21 CFR Parts 312/314/600, EMA Good Pharmacovigilance Practice, ICH E2A/E2D/E2E/E6)
- Experience overseeing all aspects of ICSR management
- Experience with aggregate report authorship
- Experience with signal detection
- Oncology drug development experience
- Familiarity with oncology-specific safety profiles
- Track record of successful health authority interactions on PV matters
- Experience managing or overseeing PV safety databases (e.g., Argus, ARISg, Oracle LSH)
- Strong scientific acumen with the ability to independently conduct and communicate benefit-risk assessments
- Excellent written and verbal communication skills
- Ability to distill complex safety information for diverse audiences
Desired Qualifications
- Experience building or significantly scaling a PV function at a clinical-stage company
- QPPV designation or experience supporting QPPV responsibilities in the EU
- Familiarity with safety considerations in Phase 3 global oncology trials and NDA/BLA submissions
- Experience with RAS/RAF/MEK pathway inhibitors or kinase inhibitors
- Fluency with regulatory intelligence tools and signal detection software
- Prior experience managing external PV partnerships and safety data exchange agreements
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