(Senior) Director, Drug Safety and Pharmacovigilance Operations
AbCellera · Vancouver
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Role summary
AbCellera seeks an experienced pharmacovigilance leader to oversee drug safety operations and framework development as the company advances to Phase 3 clinical trials. The role combines strategic vendor management with hands-on systems building to ensure regulatory compliance and scientific integrity across global programs.
What they're looking for
- 12+ years of drug safety and pharmacovigilance operations experience with relevant healthcare degree
- Expertise in global PV regulations including 21 CFR 312/600, ICH E2A–E2F, and GVP guidelines
- Proficiency with safety databases such as ARGUS, ARISg, or Veeva Vault Safety
- Demonstrated experience managing FDA, EMA, and Health Canada regulatory submissions
- Track record in monoclonal antibody development or building/scaling PV functions
What you'll be doing
- Manage external PV vendors, CROs, and safety agreements to maintain consistent practices and compliance
- Oversee safety data review, aggregate analyses, and submission of periodic and individual safety reports
- Lead safety signal detection, validation, and escalation in collaboration with clinical teams
- Ensure global PV systems compliance and case processing across international regulatory jurisdictions
- Develop risk management plans, safety governance frameworks, and inspection readiness procedures
Privacy & handoff
This role links to AbCellera's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.