Senior Director, Pharmacovigilance and Drug Safety, ...

Senior Director, Pharmacovigilance and Drug Safety, Risk Management and Safety Governance Boston, MA, USA Req #343 Thursday, February 20, 2025 Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team. What We Do: We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b "X-TOLE" study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In 2024, we are planning to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our Phase 2 "X-NOVA" clinical trial. About the Role: We are seeking a Senior Director, Pharmacovigilance and Drug Safety, Risk Management and Safety Governance , to join Xenon's department of Drug Safety and Pharmacovigilance (DSPV). This position will lead Xenon's risk management and safety governance strategy and operations by ensuring ongoing compliance with departmental procedures and global drug safety regulations throughout product lifecycle from First-in-Human (FIH) through post-marketing stages of development. The incumbent is responsible for fortifying a strong risk management infrastructure by developing, executing, and leading effective risk mitigation strategies for Xenon's clinical assets and future marketed products. Responsibilities: Develop, execute, and lead effective risk evaluation, management and mitigation strategies. Support safety physicians and safety scientists with operational aspects of Safety Governance efforts. Work cross-functionally across all departments at Xenon to implement industry best practices. Write and maintain relevant SOPs and procedures in compliance with global risk management regulations. Compile and/or review risk management-related information for aggregate safety reports. Review safety concerns escalated from internal and external stakeholders. Review potential and identified risks and contribute to the Safety Governance process. Contribute to risk management/risk mitigation-related documents for Xenon products. Communicate information/updates on Risk Management Programs for GPV activities. Review Safety Management Plan and provide input to risk management related sections of clinical study documents. Engage with cross functional teams regarding the potential or identified risk(s). Represent Pharmacovigilance in regulatory inspections and internal audits. Lead development of Risk Management documents (REMS, RMPs). Document Control: maintain electronic files for relevant DSPV documents. Act in accordance with Company policies. Some international travel may be required. Other duties as assigned. Qualifications: Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PharmD) and 12+ years of management & pharmaceutical industry experience. Experience authoring Risk Management Plans (RMPs) and contributing to risk management sections of regulatory safety reports. Prior experience with Regulatory Agency interactions. Skilled in signal detection process and managing safety information. Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance. Excellent verbal and written communication skills. Safety experience in the Neuroscience, Ophthalmology and Psychiatry therapeutic space is highly desirable. Time management skills with ability to prioritize to meet required deadlines. Ability to multitask and prioritize under tight deadlines. Ability to be flexible and adapt to change. The base salary range for this role is $264,400 to $303,800 USD ; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits. Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, only those chosen for interview will be contacted. #J-18808-Ljbffr

Created: 2025-03-08