Xenon Pharmaceuticals Inc.
Associate Director/Director, Pharmacovigilance and Drug Safety (Safety Scientist
Xenon Pharmaceuticals Inc., Boston, Massachusetts, us, 02298
Overview
Associate Director/Director, Pharmacovigilance and Drug Safety (Safety Scientist) – Join to apply for the Associate Director/Director, Pharmacovigilance and Drug Safety (Safety Scientist) role at Xenon Pharmaceuticals Inc. 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. The role involves high quality and timely scientific analysis of safety data, synthesizing data findings into clear, concise, and evidence-based statements, and collaborating with safety physicians and risk management teams for safety surveillance activities and ongoing benefit–risk analyses. We will consider exceptional candidates for relocation and/or different jurisdictions. The position reports to the Senior Director, Pharmacovigilance and Drug Safety and will be based in Boston, MA, USA in our Needham office, with hybrid requirements (minimum 2 days per week in the office) for Boston-based candidates. About Xenon
Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. 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, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. Building upon the positive results from our Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple trials evaluating azetukalner in focal onset seizures and primary generalized tonic-clonic seizures. We announced completion 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 trials in major depressive disorder (MDD) and bipolar depression (BPD). Our discovery labs pursue early-stage programs leveraging ion channel expertise, and we recently initiated Phase 1 studies for XEN1120 and XEN1701 in pain, supported by a strong balance sheet. We continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial 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 a team that performs high quality and timely scientific analysis of safety data, applies critical thinking skills and synthesizes data findings into clear, concise, and evidence-based statements. In this role the individual will collaborate with safety physicians and risk management team to perform safety surveillance activities through proactive signal detection, ongoing benefit-risk analyses, and safety monitoring/reporting activities for all Xenon’s clinical assets and future marketed products. The individual will author safety documents, review safety sections of other documents, for Xenon products throughout the product lifecycle from First-in-Human (FIH) to post-marketing, perform QC, and, when necessary, assist 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 lead, 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
Lead the proactive signal detection activities, support the ongoing benefit-risk analyses, and safety monitoring/reporting activities for Xenon products across all stages of development. Lead and manage Aggregate Safety Reports (e.g., IND/NDA Annual Reports, PADER, DSUR, PSUR, PBRER, ad-hoc regulatory responses, etc.) for Xenon products throughout product lifecycle from FIH to post-marketing in compliance with global safety regulations and guidelines and provide training within 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-related documents for Xenon products throughout product lifecycle from FIH to post-marketing such as Safety Assessment Reports, product labeling, risk management/risk mitigation-related documents, and responses to ad-hoc information requests by Health Authorities and internal stakeholders. Review safety concerns escalated from internal and external stakeholders, including competent regulatory authorities, and support safety team to develop safety related responses. Maintain continuous monitoring/updating of safety profiles for assigned investigational and marketed products. Collaborates with physicians and risk management team in ongoing risk/benefit assessment. Performs careful review of all serious events of interests and expedited individual case safety reports ensuring that the knowledge gained from these individual reports contribute to a higher degree of interpretation, consistency, and quality of the analysis at the aggregate level. Reviews and provides input to Analysis of Similar Events (AoSE), as needed. Review and communicate trending, signaling, and other safety-related issues originating from any source for the purposes of detecting and reviewing safety signals (e.g., change in frequency, nature, or severity of a safety-related issue) in a timely manner. Participates and contributes to cross-functional SRMT meetings for signal management, risk management detection, and benefit-risk assessment for Xenon products. Review potential issues and safety signals and contribute to the SRMT and Safety Governance process through the preparation and presentation of safety data; prepare and assess safety data for ongoing periodic / aggregate safety data review. Author the safety signal assessment reports in collaboration with Safety Physicians. Support the risk management team in the development of risk management strategies and activities. Review SMP and provide input to safety related sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Clinical Study Reports (CSR), SAPs, DSMB charters, and other relevant documents. Write and maintain relevant SOPs and procedures in compliance with global regulations and guidelines. Support inspections by participating in audit preparedness activities and providing requested information. Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any. Other duties as assigned. Qualifications
Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PharmD) and 8+ years (AD)/ 9+ years (Dir) of pharmaceutical industry experience in drug safety & pharmacovigilance as a Safety Scientist for products in the clinical trial and post-marketing environments. Associate Director will have a minimum of bachelor’s degree with a minimum of 8+ years management experience in a pharma or biotech environment. Director will have a minimum of bachelor’s degree with a minimum of 10+ years management experience in a pharma or biotech environment Master’s degree preferred. Ability to lead cross-functional team through all activities in the full clinical study life cycle. A good understanding of all phases of the drug development process between DSPV, Clinical, Regulatory Affairs, and other functional areas. Demonstrated ability to successfully work across a variety of teams and manage multiple conflicting priorities. Experience authoring safety signal assessment report, DSUR, PADER, PBRER, and contributing to safety and risk management sections of other regulatory safety reports (RMP, RSIs). Skilled in signal detection process and managing safety information from clinical development and post-marketing sources. Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management. Knowledge of drug development process, pharmacovigilance databases and MedDRA coding. Understanding of clinical disease state and implications of treatment. At ease with data handling and visualization, statistics, and technical writing skills. Experience with use of safety databases, preferably Argus Safety Database and signal detection tools. Strategic critical thinking skills with focus on data integrity and high-quality outputs. Excellent verbal and written communication skills with ability to communicate effectively by writing clearly and concisely, and strong presentation skills. Time management skills with ability to prioritize to meet required deadlines. Ability to multitask and prioritize under tight deadlines while providing attention to detail and high-quality work in a dynamic environment. Ability to be flexible, adapt to change, work independently, as well as experience working in a highly collaborative matrix environment. Ability to work both independently and as part of a multidisciplinary team that is results-oriented. Strong interpersonal skills and ability to foster strong collaborative relationships with internal and external team members.
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Associate Director/Director, Pharmacovigilance and Drug Safety (Safety Scientist) – Join to apply for the Associate Director/Director, Pharmacovigilance and Drug Safety (Safety Scientist) role at Xenon Pharmaceuticals Inc. 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. The role involves high quality and timely scientific analysis of safety data, synthesizing data findings into clear, concise, and evidence-based statements, and collaborating with safety physicians and risk management teams for safety surveillance activities and ongoing benefit–risk analyses. We will consider exceptional candidates for relocation and/or different jurisdictions. The position reports to the Senior Director, Pharmacovigilance and Drug Safety and will be based in Boston, MA, USA in our Needham office, with hybrid requirements (minimum 2 days per week in the office) for Boston-based candidates. About Xenon
Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. 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, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. Building upon the positive results from our Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple trials evaluating azetukalner in focal onset seizures and primary generalized tonic-clonic seizures. We announced completion 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 trials in major depressive disorder (MDD) and bipolar depression (BPD). Our discovery labs pursue early-stage programs leveraging ion channel expertise, and we recently initiated Phase 1 studies for XEN1120 and XEN1701 in pain, supported by a strong balance sheet. We continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial 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 a team that performs high quality and timely scientific analysis of safety data, applies critical thinking skills and synthesizes data findings into clear, concise, and evidence-based statements. In this role the individual will collaborate with safety physicians and risk management team to perform safety surveillance activities through proactive signal detection, ongoing benefit-risk analyses, and safety monitoring/reporting activities for all Xenon’s clinical assets and future marketed products. The individual will author safety documents, review safety sections of other documents, for Xenon products throughout the product lifecycle from First-in-Human (FIH) to post-marketing, perform QC, and, when necessary, assist 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 lead, 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
Lead the proactive signal detection activities, support the ongoing benefit-risk analyses, and safety monitoring/reporting activities for Xenon products across all stages of development. Lead and manage Aggregate Safety Reports (e.g., IND/NDA Annual Reports, PADER, DSUR, PSUR, PBRER, ad-hoc regulatory responses, etc.) for Xenon products throughout product lifecycle from FIH to post-marketing in compliance with global safety regulations and guidelines and provide training within 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-related documents for Xenon products throughout product lifecycle from FIH to post-marketing such as Safety Assessment Reports, product labeling, risk management/risk mitigation-related documents, and responses to ad-hoc information requests by Health Authorities and internal stakeholders. Review safety concerns escalated from internal and external stakeholders, including competent regulatory authorities, and support safety team to develop safety related responses. Maintain continuous monitoring/updating of safety profiles for assigned investigational and marketed products. Collaborates with physicians and risk management team in ongoing risk/benefit assessment. Performs careful review of all serious events of interests and expedited individual case safety reports ensuring that the knowledge gained from these individual reports contribute to a higher degree of interpretation, consistency, and quality of the analysis at the aggregate level. Reviews and provides input to Analysis of Similar Events (AoSE), as needed. Review and communicate trending, signaling, and other safety-related issues originating from any source for the purposes of detecting and reviewing safety signals (e.g., change in frequency, nature, or severity of a safety-related issue) in a timely manner. Participates and contributes to cross-functional SRMT meetings for signal management, risk management detection, and benefit-risk assessment for Xenon products. Review potential issues and safety signals and contribute to the SRMT and Safety Governance process through the preparation and presentation of safety data; prepare and assess safety data for ongoing periodic / aggregate safety data review. Author the safety signal assessment reports in collaboration with Safety Physicians. Support the risk management team in the development of risk management strategies and activities. Review SMP and provide input to safety related sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Clinical Study Reports (CSR), SAPs, DSMB charters, and other relevant documents. Write and maintain relevant SOPs and procedures in compliance with global regulations and guidelines. Support inspections by participating in audit preparedness activities and providing requested information. Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any. Other duties as assigned. Qualifications
Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PharmD) and 8+ years (AD)/ 9+ years (Dir) of pharmaceutical industry experience in drug safety & pharmacovigilance as a Safety Scientist for products in the clinical trial and post-marketing environments. Associate Director will have a minimum of bachelor’s degree with a minimum of 8+ years management experience in a pharma or biotech environment. Director will have a minimum of bachelor’s degree with a minimum of 10+ years management experience in a pharma or biotech environment Master’s degree preferred. Ability to lead cross-functional team through all activities in the full clinical study life cycle. A good understanding of all phases of the drug development process between DSPV, Clinical, Regulatory Affairs, and other functional areas. Demonstrated ability to successfully work across a variety of teams and manage multiple conflicting priorities. Experience authoring safety signal assessment report, DSUR, PADER, PBRER, and contributing to safety and risk management sections of other regulatory safety reports (RMP, RSIs). Skilled in signal detection process and managing safety information from clinical development and post-marketing sources. Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management. Knowledge of drug development process, pharmacovigilance databases and MedDRA coding. Understanding of clinical disease state and implications of treatment. At ease with data handling and visualization, statistics, and technical writing skills. Experience with use of safety databases, preferably Argus Safety Database and signal detection tools. Strategic critical thinking skills with focus on data integrity and high-quality outputs. Excellent verbal and written communication skills with ability to communicate effectively by writing clearly and concisely, and strong presentation skills. Time management skills with ability to prioritize to meet required deadlines. Ability to multitask and prioritize under tight deadlines while providing attention to detail and high-quality work in a dynamic environment. Ability to be flexible, adapt to change, work independently, as well as experience working in a highly collaborative matrix environment. Ability to work both independently and as part of a multidisciplinary team that is results-oriented. Strong interpersonal skills and ability to foster strong collaborative relationships with internal and external team members.
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