rezolutebio - Rezolute - Director / Senior Director, Pharmacovigilance Operations

Remote - / Redwood City3w ago

Remote Director WW Pharmaceuticals Biotechnology Executive Director Director of Operations Pharmacovigilance Risk Management Reporting Team Management Product Marketing

Requirements

• Advanced degree in a health or life sciences discipline strongly preferred, such as MD, PharmD, PhD, RN/NP, or equivalent scientific/medical training. • Candidates with a master's or bachelor's degree and significant relevant pharmacovigilance leadership experience may also be considered. • Typically 10+ years of pharmaceutical/biotechnology industry experience, including approximately 7+ years in pharmacovigilance/drug safety. • Demonstrated experience supporting late-stage clinical development and/or marketed products. • Experience managing outsourced PV operations and vendors. • Previous experience with NDA/BLA/MAA preparation, product launch, or post-marketing pharmacovigilance strongly preferred. • Senior Director: • Typically 12-15+ years of pharmaceutical/biotechnology industry experience with substantial progressive leadership responsibility within pharmacovigilance. • Demonstrated leadership of PV activities through late-stage development, regulatory approval, and commercial launch. • Experience establishing or significantly scaling a pharmacovigilance function, ideally within a small or mid-sized biotechnology company. • Experience interacting with senior executives, health authorities, strategic partners, and regulatory inspectors. • Technical Expertise • Strong working knowledge of: • Global pharmacovigilance regulations and regulatory reporting requirements • ICSR management and expedited reporting • Aggregate safety reporting • Benefit-risk assessment • Risk management planning and risk minimization • Safety governance • Safety database and PV technology environments • SDEAs and partner pharmacovigilance oversight • Vendor governance and outsourced PV models • PV quality systems, CAPAs, audits, and inspection readiness • Clinical-to-commercial PV transition • Experience with commercial safety systems such as Oracle Argus Safety or equivalent validated safety database platforms is desirable. • Leadership Competencies • The successful candidate will demonstrate: • Builder mentality: Comfortable establishing infrastructure rather than inheriting a fully mature PV organization. • Strategic judgment: Ability to distinguish immediate launch-critical requirements from capabilities that can scale after commercialization. • Scientific rigor: Strong ability to interpret complex clinical and post-marketing safety information and translate it into actionable benefit-risk assessments. • Operational discipline: Ability to establish processes, governance, controls, metrics, and vendor accountability. • Cross-functional influence: Ability to work effectively with Clinical, Regulatory, Medical Affairs, Quality, Commercial, Legal, and executive leadership. • Risk-based decision making: Ability to identify material patient-safety and compliance risks and implement pragmatic solutions in a resource-conscious biotechnology environment. • Executive communication: Ability to communicate complex safety issues clearly and concisely to senior leadership and governance committees. • Hands-on leadership: Willingness to operate both strategically and tactically in a growing organization. • Particularly attractive candidates will have experience with several of the following: • First commercial product launch • Transition from clinical-stage to commercial-stage biotechnology • NDA or BLA submission and approval • U.S. and European product launches • Building or scaling an outsourced/hybrid PV operating model • Establishing post-marketing signal detection processes • Implementing or migrating a validated safety database • PSMF development and maintenance • FDA or European health authority PV inspections • Rare disease, oncology, specialty pharmaceutical, biologic, or other relevant therapeutic-area experience • Patient support programs and specialty pharmacy safety reporting • Commercial product complaint/adverse event reconciliation • Licensing, co-development, or co-commercialization partnerships

Responsibilities

• Pharmacovigilance Strategy & Leadership • Develop and execute the pharmacovigilance strategy supporting late-stage clinical development, regulatory approval, product launch, and post-marketing surveillance. • Establish a scalable PV operating model appropriate for the company's anticipated commercial footprint, product portfolio, geographic expansion, and partnership structure. • Serve as a senior safety leader and subject matter expert for pharmacovigilance matters across Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Commercial, Legal, and other functions. • Provide safety input into clinical development plans, regulatory submissions, labeling strategies, launch-readiness activities, medical information processes, and lifecycle management. • Represent Pharmacovigilance on cross-functional governance and product development teams. • For the Senior Director level, provide strategic leadership to executive management regarding emerging safety issues, benefit-risk considerations, regulatory risk, and organizational PV capabilities. • Commercial Launch Readiness • Lead PV readiness activities required to transition from a clinical-stage to commercial-stage pharmacovigilance organization. • Establish processes for adverse event and product complaint intake from Medical Affairs, Medical Information, Commercial, Market Access, patient support programs, digital channels, distributors, partners, and other potential sources. • Partner with Quality and Commercial functions to ensure appropriate identification, triage, reconciliation, and escalation of safety information associated with product complaints. • Establish PV requirements and training for employees, contractors, vendors, field-based personnel, and other groups who may receive adverse event information. • Ensure PV systems, procedures, resources, vendors, and governance structures are operational and inspection-ready prior to product launch. • Safety Surveillance & Benefit-Risk Management • Establish and oversee processes for signal detection, validation, prioritization, assessment, management, and documentation. • Lead cross-functional safety review or Safety Management Team meetings. • Provide strategic oversight of aggregate safety reports and periodic benefit-risk assessments, including applicable DSURs, PBRERs/PSURs, and other periodic reports. • Lead or contribute to Risk Management Plans and other risk minimization activities. • Partner with Regulatory Affairs and Clinical Development on safety-related labeling changes, investigator communications, regulatory responses, and health authority interactions. • Pharmacovigilance Operations • Provide strategic and operational oversight of adverse event case management across clinical and post-marketing sources. • Ensure appropriate collection, assessment, processing, follow-up, quality review, and submission of ICSRs within applicable regulatory timelines. • Oversee PV vendors, including safety database providers, case-processing vendors, medical review resources, literature surveillance providers, and aggregate reporting partners. • Establish meaningful operational metrics, quality indicators, and vendor performance measures to monitor the effectiveness of the PV system. • Develop internal capabilities versus outsourced capabilities based on company growth, volume, geographic footprint, and portfolio requirements. • Ensure effective reconciliation of safety information across clinical databases, medical information, quality/product complaints, partners, patient support programs, and other relevant systems. • PV Quality, Compliance & Inspection Readiness • Partner closely with Quality Assurance to establish and maintain the company's pharmacovigilance quality system. • Develop, implement, and maintain PV policies, SOPs, work instructions, and controlled processes. • Establish appropriate deviation, CAPA, quality-event, and compliance-monitoring processes related to pharmacovigilance. • Maintain continuous PV inspection readiness and participate in regulatory authority inspections, partner audits, vendor audits, and internal audits. • Ensure documentation demonstrates effective oversight of outsourced PV activities. • Support development and maintenance of applicable PV system documentation and regulatory requirements, including the Pharmacovigilance System Master File (PSMF) where required. • Partnerships & Alliance Management • Develop and maintain Safety Data Exchange Agreements (SDEAs) and pharmacovigilance provisions within licensing, distribution, co-development, and commercialization agreements. • Represent the company on joint safety committees and other alliance governance forums. • Monitor partner compliance with contractual PV obligations and implement corrective actions as necessary. • Regulatory Compliance • Maintain current knowledge of applicable global pharmacovigilance regulations and guidance, including requirements of the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), ICH, and other relevant health authorities. • Ensure company PV processes remain compliant as products transition from investigational to marketed status and expand geographically. • Support preparation for health authority meetings and responses to regulatory questions regarding product safety and benefit-risk.