(Senior) Director, Drug Safety and Pharmacovigilance Operations

The role

You will spearhead the evolution of the drug safety framework and manage PV vendors and agreements. You will provide oversight for safety data review, signal detection, and global PV systems to ensure regulatory compliance.

What you will do

• Collaborate with external partners, CROs, and affiliates to manage PV vendors, agreements, and Safety Management Plans.
• Provide expert oversight for safety data review and work with Regulatory Affairs to produce and submit periodic and individual safety reports.
• Work with Medical Monitors and Clinical Scientists to facilitate safety signal detection, validation, and management.
• Ensure robust safety surveillance through continuous monitoring of clinical trials, literature, and external databases.
• Oversee global PV systems and processes including case processing and aggregate reporting.
• Lead safety-related elements of inspection readiness and manage responses to audits and regulatory inquiries.
• Work with Clinical Quality to develop and maintain SOPs and safety governance frameworks.
• Stay abreast of evolving global safety regulations, guidelines, and best practices.
• Partner with Clinical Development, Regulatory Affairs, Medical Affairs, Manufacturing, and Quality.
• Drive the development and execution of risk management plans, safety specifications, and benefit-risk assessments.

Required qualifications

• 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

• Proven track record in global safety strategy, PV operations, and regulatory engagement, ideally within the monoclonal antibody space
• Prior experience building or scaling a pharmacovigilance function

Benefits

• Equity
• Annual bonus dependent on individual and company performance
• 6% 401K contribution
• USD $1,500 annual Active Lifestyle Allowance
• Annual vacation
• Professional development opportunities
• Comprehensive health benefits
• Scientific and technical mentorship

Before you apply

• Please submit your application through our website and refer to Job ID 23390 in your cover letter.
• We are only able to contact those who are selected for an interview.

About the company

AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology.