Director/Senior Director, Pharmacovigilance and Drug Safety (Safety Scientist)

Role: Director/Senior Director, Pharmacovigilance and Drug Safety, overseeing safety surveillance and aggregate safety report development for Xenon's clinical and post-marketing products. Responsibilities: lead signal detection, perform benefit-risk analyses, author and review safety reports (e.g., DSUR, PADER, PBRER), monitor safety profiles, manage safety concerns, and support risk management strategies. Collaborate with cross-functional teams including Clinical Development, Regulatory, Medical Affairs, and Safety Physicians; participate in SRMT meetings; and ensure compliance with global pharmacovigilance regulations. Qualifications: Health Care Professional degree (RN, PharmD, etc.) with 9+ (Director) or 12+ (Senior Director) years in drug safety/pharmacovigilance; 10+ years management experience (Director) or 8+ years (Senior Director) in pharma/biotech; extensive experience with safety signal detection, safety data analysis, regulatory safety reports, and databases like Argus; strong knowledge of FDA/EMA regulations, ICH guidelines, and clinical development processes. High-Value: experience across all phases of drug development, including clinical trials and post-marketing, with expertise in neuroscience-related therapeutics; leadership in safety signal assessment and risk management; familiarity with MedDRA coding and safety database tools. Location: Boston, MA, hybrid or remote for exceptional candidates; includes managing multiple priorities in a fast-paced environment.