Xenon Seven

Xenon Seven

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

Boston · Director

Sponsorship not specifiedDetected 40 days ago
RESTStatisticsProduct ManagementClinical TrialsPharmacologyFDA RegulatoryPharmacovigilanceCommunicationCollaborationCritical ThinkingTime ManagementWritingBiostatisticsRegulatory Affairs

About the role

  • We are seeking a Director/Senior Director, Pharmacovigilance and Drug Safety (Safety Scientist) to join our Pharmacovigilance and Safety team.
  • The successful candidate is responsible for safety surveillance and development of aggregate safety reports in compliance with global drug safety regulations and departmental procedures.
  • This position reports to the Executive Director, Pharmacovigilance and Drug Safety, and will be based out of Boston, MA, USA in our Needham office.

Responsibilities

  • Review safety concerns escalated from internal and external stakeholders, including competent regulatory authorities, and support safety team to develop safety related responses.
  • 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.
  • Maintain continuous monitoring/updating of safety profiles for assigned investigational and marketed products.

Requirements

  • Senior Director will have a minimum of Master's degree with a minimum of 8+ years management experience in a pharma or biotech environment.
  • Experience leading and authoring safety signal assessment report, DSUR, PADER, PBRER, and contributing to safety and risk management sections of other regulatory safety reports (RMP, RSIs).
  • Knowledge of drug development process, pharmacovigilance databases and MedDRA coding.
  • Experience with use of safety databases, preferably Argus Safety Database and signal detection tools.
  • Excellent verbal and written communication skills with ability to communicate effectively by writing clearly and concisely, and strong presentation skills.
  • Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PharmD) and 9+ years (Dir)/12+ (Senior Dir) of pharmaceutical industry experience in drug safety & pharmacovigilance as a Safety Scientist for products in the clinical trial and post-marketing environments.
  • 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.
  • 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.
  • Understanding of clinical disease state and implications of treatment.
  • At ease with data handling and visualization, statistics, and technical writing skills.
  • Strategic critical thinking skills with focus on data integrity and high-quality outputs.

Nice to have

  • 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.

Compensation

  • 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.

Benefits

  • 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.
  • Collaborates with physicians and risk management team in ongoing risk/benefit assessment.
  • Participates and contributes to cross-functional SRMT meetings for signal management, risk management detection, and benefit-risk assessment for Xenon products.

Company info

  • Xenon Pharmaceuticals (NASDAQ:XENE https://www.nasdaq.com/market-activity/stocks/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 https://xenon-pharma.com/pipeline to address indications with high unmet medical need, including epilepsy, depression and pain. Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. In March 2026, we announced positive topline data from our Phase 3 X-TOLE2 study of azetukalner in focal onset seizures (FOS), and we anticipate submitting a New Drug Application to the Food and Drug Administration in the third quarter of 2026. Our Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication. We also have multiple Phase 3 azetukalner clinical trials underway in major depressive disorder (MDD) and bipolar depression (BPD), based on topline data from our Phase 2 X-NOVA clinical trial. In addition, we are proud of our strong heritage in human genetics, deep understanding of ion channel biology, and expertise in novel chemistries to enable potent, selective ion channel targeting. We continue to advance an early-stage pipeline of novel therapeutic candidates, including Phase 1 studies for XEN1701 (targeting Nav1.7) and XEN1120 (targeting Kv7), which are important pain targets. 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.
  • Xenon Pharmaceuticals (NASDAQ:XENE https://www.nasdaq.com/market-activity/stocks/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.
  • We are advancing an exciting product pipeline https://xenon-pharma.com/pipeline to address indications with high unmet medical need, including epilepsy, depression and pain.
  • Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications.
  • In March 2026, we announced positive topline data from our Phase 3 X-TOLE2 study of azetukalner in focal onset seizures (FOS), and we anticipate submitting a New Drug Application to the Food and Drug Administration in the third quarter of 2026.
  • Our Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication.
  • We also have multiple Phase 3 azetukalner clinical trials underway in major depressive disorder (MDD) and bipolar depression (BPD), based on topline data from our Phase 2 X-NOVA clinical trial.
  • In addition, we are proud of our strong heritage in human genetics, deep understanding of ion channel biology, and expertise in novel chemistries to enable potent, selective ion channel targeting.
  • We continue to advance an early-stage pipeline of novel therapeutic candidates, including Phase 1 studies for XEN1701 (targeting Nav1.7) and XEN1120 (targeting Kv7), which are important pain targets.
  • 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.
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