(Senior) Director, Drug Safety and Pharmacovigilance Operations

Required

• Partnering closely with Clinical Development, Regulatory Affairs, Medical Affairs, Manufacturing, and Quality to ensure integrated safety oversight and seamless execution of safety strategies
• Driving the development and execution of risk management plans, safety specifications, and benefit-risk assessments for regulatory submissions and ongoing clinical programs
• You have a proven track record in global safety strategy, PV operations, and regulatory engagement, ideally within the monoclonal antibody space
• You have at least 12 years of relevant work experience in drug safety/PV, in addition to a relevant post-secondary degree(s) in healthcare (RN, PharmD, PA, or NP)
• You have experience with safety databases (e.g., ARGUS, ARISg, Veeva Vault Safety)
• You have a demonstrated track record managing global regulatory PV submissions and health authority interactions (FDA, EMA, and Health Canada)
• You have an expert-level knowledge of global PV regulations and guidelines (e.g. 21 CFR 312/600, ICH E2A–E2F, GVP modules, WHO guidelines)
• You have prior experience building or scaling a pharmacovigilance function (preferred)