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← AbCellera

(Senior) Director, Drug Safety and Pharmacovigilance Operations

AbCellera
Location
Vancouver
Posted
18 days ago
Department
Regulatory Affairs
Salary
$160,000 - $200,000
What they actually want (must-haves)
  • Proven track record in global safety strategy, PV operations, and regulatory engagement
  • At least 12 years of relevant work experience in drug safety/PV
  • Relevant post-secondary degree(s) in healthcare (RN, PharmD, PA, or NP)
  • Experience with safety databases (e.g., ARGUS, ARISg, Veeva Vault Safety)
  • Demonstrated track record managing global regulatory PV submissions and health authority interactions (FDA, EMA, and Health Canada)
  • Expert-level knowledge of global PV regulations and guidelines (e.g. 21 CFR 312/600, ICH E2A–E2F, GVP modules, WHO guidelines)
Nice to have
  • Prior experience building or scaling a pharmacovigilance function
What the job really is

The (Senior) Director of Drug Safety and Pharmacovigilance Operations will lead the evolution of the drug safety framework during Phase 3, ensuring compliance and scientific integrity. Daily responsibilities include collaborating with external partners, overseeing safety data reviews, managing global pharmacovigilance systems, and ensuring regulatory compliance across various programs. The role also involves developing risk management plans and maintaining safety governance frameworks in partnership with multiple departments.

Benefits
  • Base salary range CAD $160,000 - $200,000 for Director role and CAD $200,000 - $245,000 for Senior Director role
  • Equity
  • Annual bonus dependent on team and company performance
  • 6% (non-match) RRSP contribution
  • CAD $1,500 annual Active Lifestyle Allowance
  • Annual vacation
Things to weigh
  • No specific mention of remote work options
  • The role involves significant collaboration with external partners, which may require flexibility in working hours
  • The job requires a strong background in monoclonal antibodies, which may limit applicability for those without this experience
Job score4.6/5
Benefits5/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency5/5

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