(Senior) Director, Drug Safety and Pharmacovigilance Operations

AbCellera•San Francisco, CA

About The Position

AbCellera is seeking an accomplished pharmacovigilance (PV) leader to evolve its drug safety framework as the company enters Phase 3. The role balances strategic oversight of external partners with hands-on systems building, while upholding scientific integrity and regulatory compliance to support regulatory filings and commercial launch. The Director will oversee global PV operations, safety data review, surveillance, signal management, safety reporting, risk management, and inspection readiness. The role partners with external vendors and internal teams across Clinical Development, Regulatory Affairs, Medical Affairs, Manufacturing, and Quality to deliver integrated safety oversight and consistent execution across programs.

Requirements

At least 12 years of relevant work experience in drug safety or pharmacovigilance.
A relevant post-secondary healthcare degree, such as RN, PharmD, PA, or NP.
Experience with safety databases such as ARGUS, ARISg, or Veeva Vault Safety.
A demonstrated track record managing global regulatory PV submissions and health authority interactions with the FDA, EMA, and Health Canada.
Expert-level knowledge of global PV regulations and guidelines, such as 21 CFR 312/600, ICH E2A–E2F, GVP modules, and WHO guidelines.

Nice To Haves

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.

Responsibilities

Manage PV vendors, agreements, and Safety Management Plans as needed in collaboration with external partners, CROs, and affiliates.
Oversee safety data review, including aggregate analyses, and work with Regulatory Affairs to prepare and submit periodic safety reports such as DSURs and PSURs, individual reports such as SUSARs and CIOMs, and responses to regulatory queries.
Work with Medical Monitors and Clinical Scientists on safety signal detection, validation, and management, including timely escalation and resolution of potential safety issues.
Continuously monitor emerging safety data from clinical trials, literature, and external databases.
Oversee global PV systems and processes, including case processing and aggregate reporting, ensuring compliance with international regulations.
Lead safety-related inspection readiness and manage responses to audits, regulatory inquiries, and corrective action plans.
Work with Clinical Quality to develop and maintain SOPs and safety governance frameworks.
Monitor evolving global safety regulations, guidelines, and best practices.
Partner with Clinical Development, Regulatory Affairs, Medical Affairs, Manufacturing, and Quality to integrate safety oversight and execute safety strategies.
Drive development and execution of risk management plans, safety specifications, and benefit-risk assessments for regulatory submissions and ongoing clinical programs.