Vice President, Pharmacovigilance & Regulatory Affairs

Function

digital_it

Business unit

Not classified

Location

Not provided

Work model

Not classified

Seniority

executive

Clearance

Not provided

Employment type

Not provided

Compensation

Not provided

First seen

2026-09-21T13:00:43.985Z

Last seen

2026-10-12T13:00:53.063Z

Requisition

vice-president-pharmacovigilance-regulatory-affa-272f981c3d

NOW HIRING POSITION SUMMARY ABOUT FENNEC www.fennecpharma.com U N I T E D S T A T E S - O N C O L O G Y VICE PRESIDENT, PHARMACOVIGILANCE & REGULATORY AFFAIRS The Vice President, Pharmacovigilance & Regulatory Affairs leads the company’s global pharmacovigilance, medical safety, and regulatory activities across the product lifecycle. The role combines executive judgment with hands-on subject-matter leadership, ensures robust safety surveillance and regulatory compliance, and provides continuity across outsourced and partner-supported operations. As the senior medical safety leader, the Vice President holds independent medical accountability for safety determinations and serves as the medical escalation point for complex or sensitive matters. The role sets regulatory strategy, directs health authority engagement, oversees submissions and commitments, and ensures emerging safety, quality, clinical, and manufacturing information is translated into appropriate regulatory and risk-management action. Are you a motivated and results-driven professional? Do you thrive in entrepreneurial environments? Are you ready to be part of a high- performing team that addresses significant unmet patient needs? Apply to join Fennec and be a part of our important mission for patients and healthcare professionals! RESPONSIBILITIES 1. Executive Leadership Provide strategic leadership and overall functional oversight for Pharmacovigilance and Regulatory Affairs, ensuring priorities, decisions, and escalation pathways are integrated. Serve as the principal point of accountability to the Chief Medical Officer for clinical safety, medical safety determinations, and regulatory strategy. Lead cross-functional assessment of matters spanning safety, quality, clinical development, manufacturing, labeling, regulatory commitments, and commercial considerations. Present decision-oriented assessments and recommendations to the Chief Medical Officer, Chief Executive Officer, executive leadership, Board, and governance committees as appropriate. Define functional capabilities, resources, budgets, and vendor support required to meet company priorities and regulatory obligations. 2. Pharmacovigilance and Medical Safety Hold independent medical signatory authority and final medical accountability for product safety within the company’s scope. Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company committed to the fight against ototoxicity in cancer patients who receive cisplatin-based chemotherapy. Fennec is focused on the commercialization of PEDMARK® to reduce the risk of platinum- induced ototoxicity in cancer patients. PEDMARK received FDA approval in September 2022 and European Commission approval in June 2023 and United Kingdom (U.K.) approval in October 2023 under the brand name PEDMARQSI®. In March 2024, Fennec entered into an exclusive licensing agreement under which Norgine Pharmaceuticals Ltd., a leading European specialist pharmaceutical company, will commercialize PEDMARQSI in Europe, U.K., Australia and New Zealand. PEDMARQSI is now commercially available in multiple countries. ® PEDMARK has received Orphan Drug Exclusivity in the U.S. and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe which includes eight years plus two years of data and market protection. Click To Learn More About Cisplatin-Induced Hearing Loss Family Stories PEDMARK (sodium thiosulfate) RESPONSIBILITIES (continued) Provide senior medical oversight for product safety assessments and serve as the escalation point for complex, high-risk, or business-critical safety matters. Lead signal detection, validation, assessment, disposition, and documentation in accordance with applicable procedures and global requirements. Lead ongoing benefit-risk assessment and maintain or oversee core safety information, risk-management content, and safety-related labeling positions. Author, review, and sign aggregate safety and benefit-risk content, including PADERs and applicable DSURs, PSURs/PBRERs, and other reports, with operational providers supporting data assembly and submission as assigned. Oversee safety information exchange with licensing partners, distributors, CROs, and vendors under PVA/SDEA arrangements, including reconciliation, issue escalation, and sponsor or MAH obligations. Provide safety oversight for clinical trials and post-marketing activities and contribute to protocols, informed consent documents, investigator materials, and risk- management strategies. Determine clinical and risk-minimization actions arising from safety findings, including labeling proposals, health authority engagement, healthcare professional communications, and additional surveillance. Provide medical input to product quality complaints and quality-led risk assessments when potential adverse-event or patient-safety implications exist. Own or oversee pharmacovigilance procedures, system documentation, inspection readiness, and medical defense of safety assessments. 3. Regulatory Affairs Set global and regional regulatory strategy for marketed and investigational products, aligned with business, clinical, safety, quality, and manufacturing priorities. Lead strategy for health authority interactions, including safety-related queries, scientific advice, labeling discussions, post-authorization commitments, and supplemental submissions. Oversee submissions, amendments, responses, briefing documents, and regulatory commitments, ensuring accurate, scientifically sound, and consistent positions. Lead product labeling strategy and governance, including evaluation of changes arising from safety, clinical, quality, manufacturing, or commercial information. Assess the regulatory implications of new data, manufacturing changes, safety signals, product quality findings, and lifecycle opportunities, and direct execution by regulatory specialists. Represent Pharmacovigilance and Regulatory Affairs in meetings with FDA and other health authorities and ensure effective preparation, presentation, documentation, and follow-through. Monitor evolving global requirements and translate changes into practical company actions, processes, and compliance priorities. 4. Operational Excellence, Vendors, and Compliance Oversee day-to-day safety operations performed internally or by external providers, including case processing, medical review, safety database activities, surveillance, and aggregate reporting. Establish performance, quality, compliance, and governance expectations for CROs, consultants, distributors, licensing partners, and other external providers. Monitor vendor performance, data quality, timeliness, reconciliation, contractual obligations, and corrective actions. Partner with Quality Assurance on audits, inspections, deviations, investigations, CAPAs, change controls, and inspection responses affecting pharmacovigilance or regulatory compliance. Ensure appropriate documentation, metrics, issue management, and inspection readiness across the functions. Promote a strong culture of patient safety, regulatory discipline, transparent escalation, and cross-functional accountability. FENNEC CORE VALUES ·ACCOUNTABILITY ·INTEGRITY ·TRUST ·RESPECT ·CELEBRATION Required M.D. or equivalent medical degree; oncology, hematology, or other directly relevant specialty training or substantive clinical experience strongly preferred. 15+ years of progressive pharmaceutical or biotechnology experience spanning pharmacovigilance, medical safety, drug development, and regulatory leadership. Demonstrated accountability for the medical safety of a marketed product and experience across clinical development and post-marketing settings. Deep expertise in individual case assessment, signal management, aggregate reporting, safety surveillance, and benefit-risk evaluation. Demonstrated experience setting regulatory strategy, leading health authority interactions, supporting submissions, and managing safety-related agency questions and commitments. Working knowledge of applicable FDA, EMA, ICH, EU GVP, PADER, risk- management, and global pharmacovigilance requirements. Experience directing CROs, vendors, licensing partners, distributors, and other external providers within an outsourced or virtual operating model. Experience supporting audits, regulatory inspections, inspection readiness, responses, and CAPA implementation. Executive presence and the ability to communicate complex scientific, medical, safety, and regulatory issues clearly to senior leadership, boards, partners, and health authorities. Ability to operate with a high degree of autonomy, sound judgment, urgency, and cross-functional influence in an entrepreneurial biotechnology environment. Preferred Pediatric oncology experience and full-lifecycle oncology development experience. Experience with global labeling, core safety information, risk-management plans, partner safety agreements, and licensed-out territories. Experience as a lead in-house physician or in an equivalent role with broad medical safety accountability. Experience with product quality risk assessment and health hazard evaluation support. Board, governance, budget, or executive business experience relevant to strategic decision-making. QUALIFICATIONS COMPENSATION AND BENEFITS SUMMARY We understand compensation is an important factor as you consider the next step in your career. Below is an overview of the compensation and benef its offerings. Base salary range: $330,000-$385,000 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualif ications of the individual applicant for the position, years of relevant experience, specif ic and unique skills, level of education attained, certif ications or other professional licenses held. Employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan, short-term and long-term disability coverage, basic life insurance, company holidays, vacation, cell phone and WiFi reimbursement, a bonus, and stock options. OUR NAME We proudly take our name from the fennec fox, a distinctively large- eared canine that is the smallest of all fox species. Their characteristic ears serve a dual purpose: they are sensitive enough to hear prey underground and also help dissipate the hot desert heat. Patients undergoing chemotherapy are going through an extraordinarily challenging time, and the loss of hearing only compounds the difficulty. Fennec Pharma, named after that resourceful and determined fennec fox, is committed to helping patients at risk of hearing loss due to ototoxicity.