Senior Director, Global Drug Safety & PV Operations
AbCellera
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Job summary
AbCellera is seeking an accomplished Pharmacovigilance Leader to drive the evolution of our drug safety framework as we enter Phase 3. Balancing strategic oversight of external partners with hands‑on systems building, you will uphold the highest standards of scientific integrity and regulatory compliance to pave the way for successful regulatory filings and commercial launch.
You will lead safety operations, manage global PV processes, strengthen regulatory engagement, and partner across
Qualifications
- Global PV strategy, operations, and regulatory engagement experience.
- 12+ years in drug safety/PV with post-secondary healthcare degree.
- Experience with safety databases and global PV submissions.
Responsibilities
- Collaborate with external partners to manage PV vendors and safety plans.
- Provide expert oversight for safety data review and regulatory reporting (DSURs, PSURs, SUSARs).
- Lead safety governance, inspections readiness, and CAPAs.
- Ensure continuous safety surveillance across trials, literature, and external data.
- Oversee global PV systems, case processing, and aggregate reporting.
Skills
Education
Tools
Job description
AbCellera is seeking an accomplished Pharmacovigilance Leader to drive the evolution of our drug safety framework as we enter Phase 3. Balancing strategic oversight of external partners with hands‑on systems building, you will uphold the highest standards of scientific integrity and regulatory compliance to pave the way for successful regulatory filings and commercial launch.
You will lead safety operations, manage global PV processes, strengthen regulatory engagement, and partner across
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