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

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