Director – Senior Director, Pharmacovigilance Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and implement a pharmacovigilance strategy to support late-stage clinical development, regulatory approvals, product launches, and post-marketing surveillance.

• Create a scalable pharmacovigilance operating model to accommodate the expected commercial footprint, product portfolio, geographic expansion, and partnership structures.

• Act as a senior safety leader and subject matter expert across various departments including Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Commercial, Legal, and others.

• Provide safety insights into clinical development plans, regulatory submissions, labeling strategies, launch-readiness initiatives, medical information processes, and lifecycle management.

• Represent the Pharmacovigilance function on cross-functional governance and product development teams.

• Lead pharmacovigilance readiness activities for the transition from clinical-stage to commercial-stage operations.

• Develop and maintain a thorough pharmacovigilance launch-readiness plan.

• Create processes for the intake, reconciliation, escalation, and reporting of adverse events and product complaints.

• Define pharmacovigilance requirements and training for employees, contractors, vendors, field-based personnel, and other groups involved in adverse event reporting.

• Ensure that pharmacovigilance systems, procedures, resources, vendors, and governance structures are operational and ready for inspection prior to product launch.

• Establish and supervise signal detection, validation, prioritization, assessment, management, and documentation processes.

• Lead cross-functional safety review meetings or Safety Management Team discussions.

• Oversee aggregate safety reports and periodic benefit-risk assessments, including DSURs, PBRERs/PSURs, and other regular reports.

• Lead or contribute to Risk Management Plans and activities aimed at risk minimization.

• Collaborate with Regulatory Affairs and Clinical Development on labeling modifications, investigator communications, regulatory responses, and interactions with health authorities.

• Provide strategic and operational oversight for adverse event case management across clinical and post-marketing sources.

• Guarantee the collection, assessment, processing, follow-up, quality review, and submission of Individual Case Safety Reports (ICSRs) within regulatory timelines.

• Manage pharmacovigilance vendors, including those for safety databases, case-processing, medical review, literature surveillance, and aggregate reporting.

• Establish operational metrics, quality indicators, and performance measures for vendors.

• Develop internal capabilities versus outsourced functions based on company growth, volume, geographic reach, and portfolio needs.

• Ensure reconciliation of safety information across clinical databases, medical information, quality/product complaints, partners, patient support programs, and other systems.

• Collaborate with Quality Assurance to establish and maintain the pharmacovigilance quality system.

• Develop, implement, and maintain pharmacovigilance policies, standard operating procedures (SOPs), work instructions, and controlled processes.

• Establish processes for deviations, corrective and preventive actions (CAPA), quality events, and compliance monitoring.

• Maintain ongoing readiness for pharmacovigilance inspections and participate in audits by regulatory authorities, partners, vendors, and internal teams.

• Ensure documentation reflects effective oversight of outsourced pharmacovigilance activities.

• Support the documentation of pharmacovigilance systems and regulatory requirements, including the Pharmacovigilance System Master File (PSMF) as necessary.

• Develop and maintain Safety Data Exchange Agreements (SDEAs) and pharmacovigilance provisions in licensing, distribution, co-development, and commercialization contracts.

• Establish responsibilities for case exchange, aggregate reporting, signal management, regulatory submissions, reconciliation, and safety governance.

• Represent the company on joint safety committees and governance forums for alliances.

• Monitor partner compliance with contractual pharmacovigilance obligations and take corrective actions as needed.

• Stay informed on global pharmacovigilance regulations and guidance, including those from the FDA, EMA, ICH, and other relevant health authorities.

• Ensure that pharmacovigilance processes remain compliant as products transition from investigational to marketed statuses and expand into new geographies.

• Support meetings with health authorities and respond to regulatory queries regarding product safety and benefit-risk evaluations.

⛳️ Requirements

• An advanced degree in a health or life sciences field is strongly preferred, such as MD, PharmD, PhD, RN/NP, or equivalent scientific/medical training.

• Candidates with a master’s or bachelor’s degree along with substantial relevant leadership experience in pharmacovigilance will also be considered.

• For the Director position: Typically requires 10+ years of experience in the pharmaceutical/biotechnology industry, with around 7+ years specifically in pharmacovigilance/drug safety.

• For the Senior Director position: Typically requires 12–15+ years of experience in the pharmaceutical/biotechnology sector with significant progressive leadership roles in pharmacovigilance.

• Proven experience in supporting late-stage clinical development and/or marketed products.

• Experience managing outsourced pharmacovigilance operations and vendors.

• For the Senior Director role: Demonstrated leadership in pharmacovigilance activities throughout late-stage development, regulatory approval, and commercial launch.

• For the Senior Director: Experience in establishing or significantly expanding a pharmacovigilance function.

• Experience in interacting with senior executives, health authorities, strategic partners, and regulatory inspectors.

• Strong familiarity with global pharmacovigilance regulations and regulatory reporting requirements.

• Solid understanding of Individual Case Safety Report (ICSR) management and expedited reporting processes.

• Strong knowledge of signal detection and management practices.

• Comprehensive understanding of aggregate safety reporting requirements.

• Proficient knowledge of benefit-risk assessment methodologies.

• Strong capabilities in risk management planning and risk minimization strategies.

• Solid understanding of safety governance frameworks.

• Strong familiarity with safety database and pharmacovigilance technology environments.

• In-depth knowledge of Safety Data Exchange Agreements (SDEAs) and partner pharmacovigilance oversight.

• Strong understanding of vendor governance and outsourced pharmacovigilance models.

• Strong knowledge of pharmacovigilance quality systems, CAPAs, audits, and inspection readiness protocols.

• Familiarity with the transition from clinical to commercial pharmacovigilance operations.

• Experience with commercial safety systems such as Oracle Argus Safety or other validated safety database platforms is desirable.

🏝️ Benefits

• Annual performance bonus.

• Health Insurance (Medical / Dental / Vision).

• Disability, Life & Long-Term Care Insurance.

• Holiday Pay.

• Tracking Free Vacation Program.

• 401(k) Plan Match.

• Educational Assistance Benefit.

• Fitness Center Reimbursement.