Pharmacovigilance Project Director

EVERSANA•Yardley, PA

About The Position

The Pharmacovigilance Project Director serves as the primary client-facing director for assigned pharmacovigilance 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 met and client objectives achieved. The director manages client relationships and communications, coordinates cross-functional teams, oversees end-to-end pharmacovigilance services, and monitors quality, performance, and project financials. The position supports regulatory inspections, audits, corrective and preventive action management, and inquiries. It also calls for modeling inclusive behaviors and contributing to diversity, equity, and inclusion. The position involves travel of less than 15% and a stated workweek of 40–45 hours. In the office environment, employees may frequently reach, grasp, stand or sit for extended periods (up to 90% of the shift), walk, talk, and hear, and may occasionally lift or move up to 25 pounds. The work environment is usually moderately quiet, with frequent interruptions and multiple demands.

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, building trusted relationships and maintaining customer satisfaction.
Use project management principles to plan, track, and drive delivery of milestones, risks, dependencies, and action items.
Lead governance forums, operational reviews, status meetings, client communications, and executive reviews, clearly communicating project progress and key decisions.
Identify, manage, and resolve client concerns, risks, and escalations.
Coordinate cross-functional teams to align responsibilities and deliver client commitments on time.
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 drive 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 ongoing development, inclusive behavior, and proactive bias management.
Perform other duties as assigned.