Vice President, Pharmacovigilance & Regulatory Affairs

NOWHIRINGPOSITION SUMMARYABOUT FENNECwww.fennecpharma.comU N I T E D S T A T E S - O N C O L O G YVICE PRESIDENT, PHARMACOVIGILANCE& REGULATORY AFFAIRSThe Vice President, Pharmacovigilance & Regulatory Affairs leads the company's globalpharmacovigilance, medical safety, and regulatory activities across the product lifecycle.The role combines executive judgment with hands-on subject-matter leadership, ensuresrobust safety surveillance and regulatory compliance, and provides continuity acrossoutsourced and partner-supported operations. As the senior medical safety leader, the Vice President holds independent medicalaccountability for safety determinations and serves as the medical escalation point forcomplex or sensitive matters. The role sets regulatory strategy, directs health authorityengagement, oversees submissions and commitments, and ensures emerging safety,quality, clinical, and manufacturing information is translated into appropriate regulatoryand risk-management action.Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on thedevelopment and commercialization of PEDMARK to reduce the risk of platinum-inducedototoxicity in pediatric patients. PEDMARK received FDA approval in September 2022,and quickly obtained NCCN Guideline status for the treatment of the AYA patientpopulation (Adolescent and Young Adult). European Commission approval was received inJune 2023, and U.K. approval in October 2023 under the brand name PEDMARQSI.PEDMARK has received Orphan Drug Exclusivity in the U.S. and PEDMARQSI has receivedPediatric Use Marketing Authorization in Europe which includes eight years plus twoyears of data and market protection. Fennec employees are expected to embrace diversity and be able to work with internalcross-functional colleagues as well as external partners from a variety of backgroundsand experiences. Additionally, the successful candidate must demonstrate excellence inintegrity and compliance with all interactions and adherence to corporate and industryguidelines. Fennec offers a fun, friendly, and industry competitive environment.Are you a motivatedand results-drivenprofessional?Do you thrive inentrepreneurialenvironments?Are you ready to bepart of a high-performing team thataddresses significantunmet patient needs? Apply to join Fennecand be a part of ourimportant mission forpatients and healthcareprofessionals!RESPONSIBILITIES 1. Executive Leadership Provide strategic leadership and overall functional oversight for Pharmacovigilanceand Regulatory Affairs, ensuring priorities, decisions, and escalation pathways areintegrated. Serve as the principal point of accountability to the Chief Medical Officer for clinicalsafety, medical safety determinations, and regulatory strategy. Lead cross-functional assessment of matters spanning safety, quality, clinicaldevelopment, manufacturing, labeling, regulatory commitments, and commercialconsiderations. Present decision-oriented assessments and recommendations to the Chief MedicalOfficer, Chief Executive Officer, executive leadership, Board, and governancecommittees as appropriate. Define functional capabilities, resources, budgets, and vendor support required tomeet company priorities and regulatory obligations. 2. Pharmacovigilance and Medical Safety Hold independent medical signatory authority and final medical accountability forproduct safety within the company's scope. Click To Learn MoreAbout Cisplatin-Induced Hearing Loss Family StoriesPEDMARK (sodium thiosulfate)RESPONSIBILITIES (continued)Provide senior medical oversight for product safety assessments and serve as theescalation point for complex, high-risk, or business-critical safety matters.Lead signal detection, validation, assessment, disposition, and documentation inaccordance with applicable procedures and global requirements. Lead ongoing benefit-risk assessment and maintain or oversee core safetyinformation, risk-management content, and safety-related labeling positions. Author, review, and sign aggregate safety and benefit-risk content, including PADERsand applicable DSURs, PSURs/PBRERs, and other reports, with operational providerssupporting data assembly and submission as assigned. Oversee safety information exchange with licensing partners, distributors, CROs, andvendors under PVA/SDEA arrangements, including reconciliation, issue escalation, andsponsor or MAH obligations. Provide safety oversight for clinical trials and post-marketing activities and contributeto 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 professionalcommunications, and additional surveillance. Provide medical input to product quality complaints and quality-led risk assessmentswhen potential adverse-event or patient-safety implications exist. Own or oversee pharmacovigilance procedures, system documentation, inspectionreadiness, 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, andsupplemental submissions. Oversee submissions, amendments, responses, briefing documents, and regulatorycommitments, ensuring accurate, scientifically sound, and consistent positions. Lead product labeling strategy and governance, including evaluation of changesarising 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 byregulatory specialists. Represent Pharmacovigilance and Regulatory Affairs in meetings with FDA and otherhealth authorities and ensure effective preparation, presentation, documentation, andfollow-through. Monitor evolving global requirements and translate changes into practical companyactions, 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, andaggregate 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, contractualobligations, and corrective actions. Partner with Quality Assurance on audits, inspections, deviations, investigations,CAPAs, change controls, and inspection responses affecting pharmacovigilance orregulatory compliance. Ensure appropriate documentation, metrics, issue management, and inspectionreadiness across the functions. Promote a strong culture of patient safety, regulatory discipline, transparentescalation, and cross-functional accountability.FENNEC CORE VALUES·ACCOUNTABILITY·INTEGRITY·TRUST·RESPECT ·CELEBRATION Required M.D. or equivalent medical degree; oncology, hematology, or other directlyrelevant specialty training or substantive clinical experience stronglypreferred. 15+ years of progressive pharmaceutical or biotechnology experience spanningpharmacovigilance, medical safety, drug development, and regulatoryleadership. Demonstrated accountability for the medical safety of a marketed product andexperience across clinical development and post-marketing settings. Deep expertise in individual case assessment, signal management, aggregatereporting, safety surveillance, and benefit-risk evaluation. Demonstrated experience setting regulatory strategy, leading health authorityinteractions, supporting submissions, and managing safety-related agencyquestions 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 otherexternal 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 biotechnologyenvironment. Preferred Pediatric oncology experience and full-lifecycle oncology developmentexperience. Experience with global labeling, core safety information, risk-managementplans, partner safety agreements, and licensed-out territories. Experience as a lead in-house physician or in an equivalent role with broadmedical safety accountability. Experience with product quality risk assessment and health hazard evaluationsupport. Board, governance, budget, or executive business experience relevant tostrategic decision-making.QUALIFICATIONSCOMPENSATION AND BENEFITS SUMMARYWe understand compensation is an important factor as you consider the next step inyour career. Below is an overview of the compensation and benefits offerings.Base salary range: $330,000-$385,000The estimated salary range reflects an anticipated range for this position. The actualbase salary offered may depend on a variety of factors, including the qualifications ofthe individual applicant for the position, years of relevant experience, specific andunique skills, level of education attained, certifications or other professional licensesheld. Employees may be eligible to participate in medical, dental, vision insurance, a401(k) plan, short-term and long-term disability coverage, basic life insurance, companyholidays, vacation, cell phone and WiFi reimbursement, a bonus, and stock options.OUR NAME We proudly take ourname from the fennecfox, a distinctively large-eared canine that is thesmallest of all foxspecies.Their characteristic earsserve a dual purpose:they are sensitiveenough to hear preyunderground and alsohelp dissipate the hotdesert heat.Patients undergoingchemotherapy are goingthrough anextraordinarilychallenging time, andthe loss of hearing onlycompounds thedifficulty. FennecPharma, named afterthat resourceful anddetermined fennec fox, iscommitted to helpingpatients at risk ofhearing loss due toototoxicity.