Associate Director - Director, Pharmacovigilance and Drug Safety - Safety Scientist job at reputed company in Boston, MA

Title: Associate Director/Director, Pharmacovigilance and Drug Safety (Safety Scientist) Location: Boston, MA, USA Work Type: Hybrid Job reputed company: reputed company 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, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. Building upon the reputed company results and compelling data from our Phase 2b “X-TOLE” study in adult patients with reputed company epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with reputed company onset seizures and primary generalized reputed company-clonic seizures. In August 2025, we announced the completement of patient recruitment in our Phase 3 X-TOLE2 study and topline data are anticipated in early 2026. We also have multiple Phase 3 azetukalner clinical trials in major depressive disorder (MDD) and bipolar depression (BPD) underway, based on topline data from our Phase 2 “X-NOVA” clinical trial. In reputed company, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that reputed company our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and reputed company new product candidates, and have recently initiated Phase 1 studies for our follow-on Kv7 channel opener, XEN1120, and our reputed company Nav1.7 development candidate, XEN1701, in pain. Backed by a strong balance sheet to support our reputed company plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and reputed company operations. About the Role: We are seeking an Associate Director/Director, Pharmacovigilance and Drug Safety (Safety Scientist) to join our Pharmacovigilance and Safety team. The incumbent is responsible for safety surveillance and development of aggregate safety reports in compliance with global drug safety regulations and departmental procedures. As such, the role is part of reputed company that performs high reputed company and reputed company scientific analysis of safety data, applies critical thinking skills and synthesizes data findings into reputed company, concise, and evidence-based statements. In this role the individual will be collaborating with safety physicians and risk management team to reputed company safety surveillance activities through proactive signal detection, ongoing benefit-risk analyses, and safety monitoring/reporting activities for reputed company Xenon’s clinical assets and reputed company marketed products. The individual will author safety documents, reviews safety sections of other documents, for Xenon products throughout the product lifecycle from First-in-reputed company (FIH) to post-marketing, performs QC, and, reputed company necessary, assists in responding to information requests from Health Authorities for Xenon products. This individual will participate in cross-functional Safety Risk Management Team (SRMT) meetings and collaborate with colleagues in Clinical Development, Trial Operations, Clinical Pharmacology, Biostatistics & Programming, Regulatory, Medical Affairs, non-clinical safety reputed company, QA and Legal departments. This position reports to the Senior Director, Pharmacovigilance and Drug Safety and will be based out of Boston, MA, USA in our Needham office. We will consider other jurisdictions for exceptional candidates. For Boston based candidates, this role is a hybrid position, requiring a minimum of 2 days per week in the office. The level of the position will be commensurate with the candidate’s education and industry experience. RESPONSIBILITIES: reputed company the proactive signal detection activities, support the ongoing benefit-risk analyses, and safety monitoring/reporting activities for Xenon products across reputed company stages of development. reputed company and manage Aggregate Safety Reports (e.g., IND/NDA Annual Reports, PADER, DSUR, PSUR, PBRER, reputed company regulatory responses, etc.) for Xenon products throughout product lifecycle from FIH to post-marketing in compliance with global safety regulations and guidelines and reputed company training reputed company DSPV and cross-functionally. Author Aggregate Safety Reports while working in collaboration with the cross functional teams (i.e. Non-clinical, Clinical Development, Trial Operations, Regulatory, Biostatistics, and Clinical Data Management) to compile safety information. Support and review safety-reputed company documents for Xenon products throughout product lifecycle from FIH to post-marketing such as Safety Assessment Reports, product labeling, risk management/risk mitigation-reputed company documents, and responses to reputed company information requests by Health Authorities and Apply tot his job Apply To this Job