Pharmacovigilance Project Director
About The Position
This position is the primary client-facing pharmacovigilance director for assigned client programs, providing strategic oversight, operational governance, and delivery leadership. The role oversees pharmacovigilance operations, client governance, inspection readiness, regulatory compliance, and service delivery while ensuring project milestones are completed and client objectives are achieved. The director builds trusted client relationships, leads governance and operational reviews, coordinates cross-functional teams, and manages client concerns, risks, and escalations. The role oversees pharmacovigilance services including case processing, aggregate reporting, literature surveillance, signal management, and regulatory submissions; drives Safety Management Plan development and maintenance; and monitors service quality, KPIs, client feedback, project financials, and contractual and operational expectations. The position also supports audits, inspections, CAPA management, and regulatory inquiries, and ensures compliance with FDA, EMA, ICH, and client-specific requirements. The role requires 40–45 hours per week and travel of less than 15%. The work environment is an office setting with frequent interruptions and multiple demands. Employees are frequently required to reach, grasp, stand and/or sit for extended periods, walk, talk, and hear, and occasionally lift or move up to 25 pounds.
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline.
- 10 or more years of pharmacovigilance experience.
- 5 or more years of client-facing project leadership experience.
- Strong knowledge of FDA, EMA, ICH, and global pharmacovigilance regulations.
- Experience supporting inspections and audits.
- Experience overseeing end-to-end pharmacovigilance services.
- Excellent communication, stakeholder management, and presentation skills.
- Ability to manage multiple complex client programs and priorities.
Nice To Haves
- Advanced degree in Life Sciences, Pharmacy, Nursing, or a related discipline.
- CRO or pharmacovigilance services experience.
- Experience managing pharmaceutical and biotechnology clients.
- PMP certification.
- Experience with project management tools.
- Demonstrated record of client satisfaction and operational excellence.
Responsibilities
- Serve as the primary point of contact for assigned clients and build trusted relationships that support customer satisfaction.
- Use project management principles to plan, track, and drive milestones, risks, dependencies, and action items.
- Lead governance meetings, operational reviews, status meetings, executive reviews, and client communications.
- Identify, manage, and resolve client concerns, risks, and escalations.
- Coordinate cross-functional teams to ensure alignment, accountability, and timely delivery of client commitments.
- Oversee case processing, aggregate reporting, literature surveillance, signal management, and regulatory submissions.
- Drive development and maintenance of Safety Management Plans.
- Monitor KPIs, quality metrics, and client feedback to support service delivery excellence and meet or exceed contractual and operational expectations.
- Ensure compliance with FDA, EMA, ICH, and client-specific requirements.
- Support audits, inspections, CAPA management, and regulatory inquiries.
- Monitor project financials, including billing, invoicing, resource utilization, and budget performance.
- Demonstrate commitment to diversity, equity, and inclusion through continuous development, inclusive behaviors, and proactive management of bias.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Director
