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

Boston, MA, USA ● Vancouver, BC, Canada Req #139 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.

We are seeking an Associate Director/Director of Drug Safety and Pharmacovigilance (Operations) to join our team. As case management and operations lead, the incumbent will lead the implementation of the global drug safety database. They will also monitor all case processing 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. The incumbent will act as operational lead for vendor oversight, budgeting, PV compliance and key performance indicators, workflow management, and training metrics. This individual also serves as lead, subject matter expert (SME), and system administrator for the Argus global safety database (GSDB). Responsible for reports writing and vendor management for GSDB hosting related activities. Serves as lead for data migration, PV compliance and inspection /audit readiness for Argus related and safety operations activities. 

This position reports to the Senior Vice President, Drug Safety and Pharmacovigilance, and will be located in either the Vancouver, BC, Canada or Boston, MA, USA location. US Remote positions (NY, NJ, CT, DE, CA) will be considered for exceptional candidates.  
RESPONSIBILITIES: 

• Provides oversight of case processing activities for the Xenon clinical development program and serves as Argus global safety database (GSDB) subject matter expert (SME)Provides operational leadership for case management workflow, overseeing the vendor case processing activities in Argus and ensuring critical timelines and compliance metrics are met. 
• Lead  the GSDB implementation & validation, and data migration 
• Acts as system administrator for the global safety database (Argus). Provides vendor oversight to the Argus cloud hosting provider (CHP), coordinates the GSDB implementation and data migration, and establishes roles and responsibilities between sponsor and CHP in day-to-day operations and preparation for audits and inspections. 
• Works closely with Xenon IT in developing processes and providing oversight for the data security and data protection of the GSDB, disaster recovery and business continuity, In partnership with the System Owner (the SVP of drug safety and pharmacovigilance), provides oversight to the quality management system and inspection readiness for Argus  Responsible for reports writing and vendor management for related activities Serves as SME/lead for PV compliance and inspection and audit readiness for all Argus, workflow, KPI’s, and case management- related topics. 
• Collaborates with other Xenon personnel and other functions to prepare safety data and Argus reports as needed Participates in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports (CSRs)Monitors and ensures compliance with worldwide regulations, SUSAR reporting to RAs adhering to regulatory reporting timelines, workflow deliverables, and KPIs for DSPV (including generation of Compliance Reports for the respective activities)Monitors activities of CROs/business partners to ensure adherence and compliance with applicable Safety Monitoring Plans, other study plans, and contractual agreements.  
• Collaborates with data management and other stakeholders as appropriate for safety data reconciliation; follows up with sites for resolving any discrepancies. 
• Collaborates with Medical Directors, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, and PV Vendor’s clinical staff in providing pharmacovigilance support for ongoing clinical trials to ensure safety data collection, review, processing, querying, and reporting. 
• Develops SOPs, Wis, and SOPs in collaboration with the CROs and other functions.  
• Participates and leads as appropriate DSPV and cross-functional program team meetings as well as vendor oversight meetings where operational items are discussed and addressed on a regular basis. 
• Provides direct vendor oversight for the generation of validated safety reports and complex queries from the GSDB.  
• Contributes to signaling and safety surveillance process, including the identification of safety observations, emergent safety concerns and new safety signals, through the preparation of reports and data outputs and by ensuring prompt assessment of safety signals. 
• Collaborates with safety physicians and the SVP of drug safety, clinical data management, biostatistics, safety vendors, and others as appropriate in developing the strategy for safety data review and for preparing safety data outputs. 
• Contributes to preparation and review of responses to health authority queries, as well as the assembly and production of aggregate safety reports such as IND Safety Report, Development Safety Update Reports (DSURs), and SUSAR listings in collaboration with safety physicians and external safety vendor. 
• Collaborates with clinical teams and other stakeholders in developing data quality standards for clinical studies, ongoing data review and query follow up, and vendor oversight. 
• Supports the completion of CSRs by reviewing safety data, patient narratives, and safety sections of the documents. 
• Contributes to the preparation of data outputs for Data Safety Monitoring Board meetings in partnership with Biostatistics. 
• In collaboration with the head of DSPV and QA, participates in the coordination of global inspection readiness activities for PV audits and inspections of Xenon products. 
• Assists the SVP of DSPV in the preparation, facilitation, and documentation of safety governance meetings 
• Provides Safety Reporting training at investigator meetings as needed. 
• Serves as lead for the development of the Training Curriculum for DSPV and in the oversight of the Training Curriculum for the PV vendors. 
• Responsible for managing the budgets, change orders, and invoices for PV vendors and consultants  
• International travel may be required. 
• 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: 

• 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 in pharmacovigilance with a focus on operations is required. 
• Prior experience in GSDB implementation, validation, and data migration is required. 
• Working experience with safety databases (preferably Argus) and analytics. 
• Experience working with and providing oversight to PV vendors and hosting partners.   
• Knowledge of ICH, US & EU regulations, and requirements for pharmacovigilance. 
• Experience in data outputs preparation for performing drug safety reports including periodic reports (DSUR, PBRER).