Senior Director, Pharmacovigilance and Drug Safety, Risk Management and Safety Governance - BioTalent Canada : Job Details

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Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. 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 potassium channel modulator in 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 2024, we are planning to initiate a Phase 3 azetukalner program in major depressive disorder, 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. 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 a Senior Director, Pharmacovigilance and Drug Safety, Risk Management and Safety Governance, to join Xenon's department of Drug Safety and Pharmacovigilance (DSPV). This position will lead Xenon's risk management and safety governance strategy and operations by ensuring ongoing compliance with departmental procedures and global drug safety regulations throughout product lifecycle from First-in-Human (FIH) through post-marketing stages of development. The incumbent is responsible for fortifying a strong risk management infrastructure by developing, executing, and leading effective risk mitigation strategies for Xenon's clinical assets and future marketed products. The individual will author risk management documents, review relevant risk management sections of other documents, contribute to aggregate safety reports, and, when necessary, assist in responding to information requests from Health Authorities for Xenon products. In situations where advanced safety monitoring and/or reporting is required [i.e. – Events of Special Interest, Risk Management Plans (RMP/RMMs), Post Approval Studies (PAS), Risk Evaluation and Mitigation Strategies (REMS), etc.], the Senior Director will engage the Safety Governance Team and lead the development and implementation of any internal procedures, labeling/marketing materials, or reports for Health Authorities that are necessary to ensure the safe use of a Xenon product. This individual will participate in cross-functional Safety Governance meetings, provide guidance on industry best practices and regulatory requirements for risk management activities, and collaborate with colleagues in Clinical Development, Trial Operations, Regulatory Affairs, Medical Affairs, Clinical Pharmacology, Biostatistics & Programming, Quality Assurance, and Legal departments. This position communicates regularly with Xenon senior management regarding any risk identification, mitigation, or compliance finding that potentially impacts the benefit-risk profile of Xenon's clinical assets and marketed products.

This position reports to the Senior Vice President, Pharmacovigilance and Safety Officer and will be in Boston, MA, USA. 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:

• Develop, execute, and lead effective risk evaluation, management and mitigation strategies. Together with lead safety physicians and safety scientists, contribute to proactive signal detection, ongoing benefit-risk analyses, safety monitoring, and reporting activities for Xenon products across all stages of development.
• Support safety physicians and safety scientists with operational aspects of Safety Governance efforts and ensure continuous harmonized operations of the risk management activities.
• Work cross-functionally across all departments at Xenon to implement industry best practices intended to enhance compliance with risk management-related regulations.
• Write and maintain relevant SOPs and procedures in compliance with global risk management regulations and guidelines and maintain the highest standards for integrated functioning and global compliance to achieve business objectives and best practice under all applicable laws, guidelines, corporate policies, and SOPs.
• Compile and/or review risk management-related information for aggregate safety reports in support of periodic safety data review meetings, including tracking of special topics or events of interests that may impact benefit/risk.
• Review safety concerns escalated from internal and external stakeholders, including competent regulatory authorities that may require risk management evaluation, and may lead to the development of risk management strategies in collaboration with lead safety scientists, safety physicians, and the Head of DSPV.
• Review potential and identified risks and contribute to the Safety Governance process as a Risk Management (RM) subject matter expert (SME), ensuring alignment between risk management strategies and recommendations presented for review and approval by Safety Governance committees.
• In accordance with Xenon procedures, contribute to risk management/risk mitigation-related documents for Xenon products throughout the product lifecycle from FIH to post-marketing, including Annual Reports, Aggregate Reports, Safety Assessment Reports, Prescriber/Patient Educational Materials, Product Labeling, and responses to ad-hoc information requests by Health Authorities and internal stakeholders.
• Communicate information/updates on Risk Management Programs for GPV activities, including updates for the Periodic Benefit Risk Evaluation Report (PBRER) and Development Safety Update Report (DSUR).
• Review Safety Management Plan and provide input to risk management-related sections of clinical study documents including Protocols, Informed Consent Forms (ICF), Clinical Study Reports (CSR), Pharmacy Manuals, etc.
• Engage with cross-functional teams regarding the potential or identified risk(s) and provide expert guidance when recommending additional risk minimization measures to ensure continued safe use of a Xenon product.
• Represent Pharmacovigilance in regulatory inspections and internal audits both locally and globally concerning risk management activities (including REMS programs in the US).
• Lead the development of Risk Management documents (REMS, RMPs) and updates/maintenance of expectedness guides.
• Ensure that Safety Governance Charters reflect all Risk Management responsibilities, timelines, deliverables mandated by regulators, from cross-functional departments and external providers.
• As a RM subject matter expert (SME), contribute and review risk management and/or REMS related information in publications, training materials, and marketing/sales pieces.
• Engage and participate in industry meeting forums, including discussions held by regulators, based on being regarded as RM SME for the company.
• Participate in ad-hoc projects or assignments that require risk management input, supporting a desired high-performance “Safety First” culture in line with Xenon's values, and reinforcing related behaviors.
• In situations where enhanced risk identification, mitigation, monitoring, or reporting is required [i.e. Risk Evaluation and Mitigation Strategies (REMS) in the US], for preventing, monitoring, and/or managing a specific safety risk and actions must be taken to reduce the frequency and/or severity of the event as a post-marketing commitment; this role will, in accordance with Xenon procedures, contribute to the following:

o Lead development and implementation of REMS processes, documents, workflows, or training sessions necessary to support enhanced risk management activities in collaboration with Regulatory Affairs, Medical Affairs, Clinical Development, and Marketing teams and Health Authorities.

o Report or respond to Health Authorities Information Requests related to risk management activities.

o Communication with FDA and business partners in close collaboration with Regulatory Affairs, on matters related to the development and maintenance of REMS programs, REMS modifications, Assessment Reports, Dear Healthcare Professional Communications, Medication Guide, and inspections.

o Ensure adherence to REMS requirements and act where needed on REMS program's “Elements to Assure Safe Use” (ETASUs) through ongoing monitoring of established metrics, tracking logs, and documentation.

o Conduct vendor selection and contract negotiation/renewals according to company policies when the need to procure external providers has been determined by the REMS Team.

o Serve as a liaison between Xenon and its vendors, ensuring vendor compliance with REMS requirements and contractual obligations. Implement routine vendor audit processes and CAPAs with PV Operations & QA.

o Direct internal groups and external vendors or consultants pertaining to the development of the REMS Assessment Reports (RAR) and ensure the completeness and timely production according to the timetable for submission of assessments.

o Ensure implementation of FDA-approved changes to REMS programs and measures the effectiveness of those changes, revising REMS materials when identified internally or by FDA.

o Ensure SOPs concerning Xenon's risk management system are developed and maintained.

• Document Control: maintain electronic files for relevant DSPV documents on the Xenon SharePoint or shared drives or other systems.
• 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.
• Some international travel may be required.
• Other duties as assigned.

QUALIFICATIONS:

• Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PharmD) and 12+ years of management & pharmaceutical industry experience in Drug Safety & Pharmacovigilance Risk Management for products in the clinical trial and post-marketing environments or MD with 8+ years of clinical experience and 6+ years of management and pharmaceutical industry experience in Safety Risk Management, while supporting Clinical Development, or Clinical Research and Regulatory Affairs functions is preferred.
• Experience authoring Risk Management Plans (RMPs), Risk Assessment Reports (RARs) and contributing to risk management sections of other regulatory safety reports (DSUR, PBRER, and RSIs).
• Prior experience with Regulatory Agency interactions including health authority inspections, label and RMP/REMS negotiations, response to clinical information requests, etc.
• Skilled in signal detection process and managing safety information from clinical development and post-marketing sources as it relates to risk management activities.
• Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management.
• Excellent verbal and written communication skills with the ability to write clearly and concisely, and strong presentation skills.
• Safety experience in the Neuroscience, Ophthalmology, and Psychiatry therapeutic space is highly desirable.
• Time management skills with the 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.

The base salary range for this role is $264,400 to $303,800 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.

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.