Associate Director/Director, Drug Safety and Pharmacovigilance Operations and Systems

Who We Are:

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 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 leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates, and have recently initiated Phase 1 studies for our follow-on Kv7 channel opener, XEN1120, and our lead 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, Drug Safety and Pharmacovigilance Operations and Systems to join our team. This important role in the Pharmacovigilance Operations (PV Ops) team will be responsible for the maintenance and oversight of appropriate procedures and systems to assure adherence to local and international regulatory requirements for collection, processing, and reporting of safety information throughout the product life cycle. They may be deployed to one or more of the key areas of process and performance excellence within the Pharmacovigilance Operations remit: safety report case management, quality & compliance, safety agreements, safety systems, and vendor management.

This position reports to the Executive Director, Pharmacovigilance & Drug Safety Operations & Systems, and will be based out of Boston, MA, USA in our Needham office. For Boston based candidates, this role is a hybrid position, requiring a minimum of 2 days per week in the office. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience.

RESPONSIBILITIES:

• Act as a DSPV Operations study lead for case management including but not limited to vendor oversight, forecasting, budgeting, compliance, key performance indicators, and training.
• Assist with operational leadership for case management workflow, overseeing case processing activities and ensuring critical timelines and compliance metrics are met.
• Collaborate with data management and other stakeholders as appropriate for safety data reconciliation; follows up to facilitate prompt resolution of any discrepancies.
• Serve as a SME for DSPV compliance and inspection and audit readiness for case management- related topics.
• Collaborate with DSPV personnel to prepare safety data listings and reports as needed.
• Assist with safety database maintenance activities including but not limited to validation, data migration and associated change management actions.
• Assist in management of PV mailboxes and distribution lists.
• Monitor and ensure compliance with worldwide regulations, safety reporting to RAs, Investigator/ECs, and Business Partners adhering to regulatory reporting timelines, workflow deliverables, and KPIs for DSPV (including generation of Compliance Reports for the respective activities).
• Serve as a SME for PV compliance, PV Agreements, and inspection and audit readiness for compliance and quality related topics.
• Author and maintain pharmacovigilance agreements, including but not limited to safety data exchange agreements, safety handling plans, and safety management plans.
• Monitor activities of CROs/business partners to ensure adherence and compliance with applicable study protocols, Safety Management Plans, applicable SOPs and WIs, other study plans, metrics, and contractual agreements.
• Assist in development and maintenance of SOPs, WIs, and procedural guidance documents in collaboration with other functions.
• Participate and lead, as appropriate, DSPV and cross-functional program team meetings and vendor oversight meetings where operational items are discussed.
• Provide vendor oversight for the generation of validated safety reports from the safety database.
• Collaborate with safety physicians and other members of DSPV, clinical data management, biostatistics, safety vendors, and others as appropriate in developing the strategy for safety data review and for preparing safety data outputs.
• Assist in the preparation and review of responses to health authority queries, as well as the assembly and production of aggregate safety reports.
• Prepare and provide training for DSPV team, PV and non-PV vendors, and safety reporting training at Investigator meetings as applicable.
• 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.
• Some international travel may be required.
  
  

QUALIFICATIONS:

• Health Care Professional degree preferred (e.g., RN/BSN/MSN, NP, PharmD). A Bachelor of Science Degree in Life Sciences combined with relevant experience will be considered.
• Associate Director will have a minimum of a bachelor’s degree with a minimum of 8 years management experience in the pharmaceutical industry experience in drug safety & pharmacovigilance operations for products in the clinical trial and post-marketing environments or combination of degrees and experience.
• Director will have a minimum of a bachelor’s degree with a minimum of 10 years management experience in the pharmaceutical industry experience in drug safety & pharmacovigilance operations for products in the clinical trial and post-marketing environments or combination of degrees and experience. A master’s degree is preferred.
• Five years of experience working with and providing oversight to PV vendors and/or hosting partners.
• Experience in preparation and review of data outputs for aggregate safety report generation (i.e., DSUR, PBRER).
• Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance.
• 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 data visualization/analytics applications.
• 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 be flexible, adapt to change, work independently, as well as experience working in a highly collaborative matrix environment.
  
  

The base salary range for this role is $171,000 to $243,000 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. 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 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: Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here.

To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.