Director / Senior Director, Pharmacovigilance Operations

Key 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.
• Develop and maintain a comprehensive PV launch-readiness plan, including commercial adverse event intake, case processing, reconciliation, vendor interfaces, escalation pathways, reporting responsibilities, and business continuity.
• 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.
• Establish clear responsibilities for case exchange, aggregate reporting, signal management, regulatory submissions, reconciliation, and safety governance.
• 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.

Qualifications

Education

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.

Experience

• Director: 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

• Global pharmacovigilance regulations and regulatory reporting requirements
• ICSR management and expedited reporting
• Signal detection and signal management
• 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

• 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.

Preferred Experience

• 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