Pharmacovigilance Project Director
About The Position
The Pharmacovigilance Project Director serves as 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 to ensure project milestones are achieved and client objectives are met. The director leads client relationships and communications, coordinates cross-functional teams, oversees end-to-end pharmacovigilance services, and monitors service quality, financial performance, and compliance. The position also supports audits, inspections, CAPA management, and regulatory inquiries. The role requires 40–45 hours per week and travel of less than 15%.
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, build trusted relationships, and ensure high customer satisfaction.
- Plan, track, and drive project milestones, risks, dependencies, and action items using project management principles.
- 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 execution of client commitments.
- Oversee case processing, aggregate reporting, literature surveillance, signal management, and regulatory submissions.
- Drive the development and maintenance of Safety Management Plans.
- Monitor KPIs, quality metrics, and client feedback to promote 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 continued development, inclusive behavior, and proactive bias management.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Director
