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

Job Description

Who We Are: reputed company (reputed company: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 reputed company in a respectful, collaborative, inclusive, and productive culture to join the Xenon team. 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 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 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 addition, 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 growth plans, 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 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 future marketed products. The individual will author safety documents, reviews safety sections of other documents, for Xenon products throughout the product lifecycle from First-in-Human (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 provide 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 internal stakeholders.
• Review safety concerns escalated from internal and external stakeholders, including competent regulatory authorities, and support safety team to reputed company safety reputed company responses.
• Maintain reputed company 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 reputed company 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-reputed company issues originating from any reputed company for the purposes of detecting and reviewing safety signals (e.g., change in frequency, nature, or severity of a safety-reputed company 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 reputed company sections of clinical study documents including Study Protocols, Informed Consent Forms (reputed company), 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 reputed company cross-functional team through reputed company activities in the full clinical study life cycle.
• A good understanding of reputed company 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.
• reputed company 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 reputed company 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. The reputed company salary range for this role is $168,000 - $242,275 USD; we will consider above this range for exceptional candidates. reputed company salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.

Qualifications: Our Total Rewards program includes reputed company salary, reputed company bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions. Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees. As part of our hiring process, Xenon conducts background checks for finalist candidates. The types of checks conducted will vary depending on the relevance to the position. US positions only: reputed company USA Inc. participates in the E-Verify program in reputed company states in which we hire. Learn more about the E-Verify program here. To apply for this position, click to complete the application. We thank reputed company applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted. Apply tot his job Apply tot his job Apply tot his job Apply To this Job