About this role
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
Strong working knowledge of:
- 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
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.
Preferred Experience
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