Associate Director/Director, Pharmacovigilance and Drug Safety (Safety Scientist)
Xenon Pharmaceuticals (NASDAQ:XENE) – a biopharmaceutical company with operations in Vancouver, BC, Canada and Boston, MA, USA – is committed to delivering innovative medicines to provide a brighter future for patients suffering from neurological disorders.
At Xenon, we are advancing an exciting pipeline of neurology-focused therapies, with a particular emphasis on novel treatments for both adult and pediatric patients with epilepsy. XEN496 is currently being evaluated in the Phase 3 “EPIK” clinical trial in young patients with KCNQ2-DEE, a rare and severe form of childhood epilepsy. Late-stage development plans are also underway for our XEN1101 program, building upon the compelling data from the Phase 2b “X-TOLE” study in adult patients with focal epilepsy. We are also proud of the leading-edge science coming out of our discovery labs, with many early-stage research programs underway. In addition to Xenon’s proprietary programs, we have ongoing collaborations with our valued pharmaceutical partners. With a healthy balance sheet to support our growth plans, we continue to build a fully-integrated, premier neuroscience company with strong discovery, development, and commercial operations.
Our employees are smart, passionate, dedicated, and driven by their incredibly important work to discover, develop, and deliver new medicines for patients in need. Building and maintaining a respectful, collaborative, inclusive, and productive culture is a priority for us. We are looking for great people who thrive in a fast-paced, dynamic work environment to join our team during this transformative time for Xenon. To learn more about job opportunities at Xenon, please visit www.xenon-pharma.com.
We are seeking an Associate Director/Director, Pharmacovigilance and Drug Safety (Safety Scientist) to join our team. The incumbent will provide pharmacovigilance and drug safety scientific and operational expertise to the pharmacovigilance department for Xenon’s clinical development program. This individual will conduct case processing activities as needed and aggregate data review for Xenon’s clinical drugs to support product safety and compliance with global drug safety regulations and departmental procedures and provide vendor oversight to CROs for HCP steps of case processing activities. The lead will also contribute to the triage, case review, narrative writing, analysis of similar events of the Individual Case Safety Reports (ICSR) and Periodic Reports for Xenon’s investigational products. This individual also provides pharmacovigilance oversight for Xenon’s products, including safety scientific input for safety surveillance, signal detection, benefit-risk assessment, and risk management activities. They will be responsible for the pharmacovigilance compliance program, including SOP/Work Instruction/Safety Management Plan (SMP) development, vendor management of relevant activities, KPIs and metrics development and oversight, and inspection and audit readiness.
This position reports to the Senior Vice President, Pharmacovigilance and Drug Safety and will be located in either the Vancouver, BC, Canada or Boston, MA, USA location; we may consider other locations for an exceptional candidate.
- Perform triage for incoming cases (assessing seriousness, expectedness, and relatedness) and relevant aspects of medical review in collaboration with the safety physicians and medical directors
- Author high quality case narratives, and collaborates on the development of analyses of similar events for the medical review of ICSR’s including identifying relevant information from source documents
- Contribute to the production of accurate safety reports (ICSRs) (i.e., CIOMS/MedWatch Forms) for submission to regulatory authorities and partners
- Track and monitor day zero and due dates for regulatory submissions in collaboration with the regulatory documents
- Provide oversight to reconciliation of the safety and clinical databases for serious adverse events
- Conduct peer review of cases in the safety database for quality control (quality review step in the global safety database); participate as needed in GSDB implementation, data migration, and workflow management activities
- Generate safety queries as needed for clarification of clinical reports
- Conduct active case follow-up, including written and verbal follow-up with clinical investigators and sites
- Support the management of case processing deadlines in collaboration with the workflow manager
- Configure and run safety line listings/reports in the global safety database (standard and custom reports including use of advanced conditions)
- Compile safety information for aggregate safety reports in support of the aggregate safety data review meetings and periodic safety reviews
- Contribute to the safety sections of clinical study protocol synopses, study protocols, ICF, IB, INDs, DSURs, and CSRs
- Conduct and facilitate review of safety data for the aggregate safety data review meetings on a periodic basis and as required; manage the safety profile review and signal management in the context of the aggregate data review
- Conduct review of final drafts of the IND annual safety reports/DSURs in collaboration with other stakeholders
- Author SOPs and WIs
- Author SMPs in collaboration with CRO and other Xenon functions, and facilitate activities during project/study start-up phase, including cross-functional interactions
- Lead and facilitate department meetings; prepare agendas and meeting minutes; assist with vendor management and oversight
- Provide oversight of MedDRA and WHO Drug coding
- In collaboration with other stakeholders, review the RMP strategy, including elements that require strategic cross-functional input and alignment
- Review safety concerns escalated from internal and external stakeholders, including competent regulatory authorities, and develop strategies for safety assessment in collaboration with the DSPV department head
- 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
- Review potential issues and safety signals and contribute to the Safety Governance process through the preparation and presentation of safety data; prepare and assess safety data for ongoing periodic / aggregate safety data reviews, and provide recommendations for review and approval by the Safety Advisory Committee
- Work across cross-functional areas including but not limited to Clinical Development and Operations functions, Regulatory, Biostatistics, and Clinical Data Management to facilitate cross-functional reviews of safety data
- 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
- Master’s degree in relevant field (Life sciences), nursing degree or pharmacy degree required; for exceptional candidates, a Bachelor of Science Degree in Life Sciences combined with relevant experience will be considered
- 8+ years of experience drug safety and pharmacovigilance in the pharmaceutical industry in a CRO or pharmaceutical setting
- Strong understanding of local and applicable global safety regulations, medical terminology, and drug development process
- Strong clinical background, with ability to interpret medical records (e.g. laboratory results, medical records)
- Experience with use of safety databases, preferably Argus Safety Database
- Excellent verbal and written communication skills with ability to write 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 matrix environment