Senior Director, Drug Safety & Pharmacovigilance
Company: Health Care Administrators Association® (HCAA)
- Location: Philadelphia, United States
- Seniority: Director
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Senior Director, Safety & Pharmacovigilance
Lead global safety strategy for a rare disease pipeline, including safety surveillance, signal detection, benefit-risk assessment, and risk management for clinical-stage programs.
Key Responsibilities
- Own pharmacovigilance activities, including case processing and preparation of aggregate safety reports.
- Ensure compliance with FDA, EMA, and ICH requirements.
- Conduct safety governance activities, including risk management planning and oversight.
- Manage and partner with pharmacovigilance vendors to maintain quality and performance.
- Partner cross-functionally with Clinical Development, Regulatory, and Quality to align safety decisions and documentation.
- Support regulatory inspections, audits, and ongoing quality improvements.
- Build, mentor, and lead a high-performing pharmacovigilance team.
Qualifications & Skills
- Strong leadership in safety strategy and pharmacovigilance operations.
- Expertise in signal detection, benefit-risk assessment, and risk management.
- Deep understanding of global regulatory frameworks (FDA/EMA/ICH).
- Experience overseeing PV processes, reporting, vendor management, and inspection readiness.
- Excellent cross-functional collaboration and governance capabilities.
