Pharmacovigilance Project Director

EVERSANA•Yardley, PA

1d•$120,000 - $135,000

About The Position

The Pharmacovigilance Project Director serves as the primary client-facing pharmacovigilance director for assigned client programs. The role provides strategic oversight, operational governance, and delivery leadership across pharmacovigilance operations, client governance, inspection readiness, regulatory compliance, and service delivery, while ensuring project milestones are met and client objectives are achieved. The director builds trusted client relationships and coordinates cross-functional teams to deliver client commitments. The position oversees pharmacovigilance services, including case processing, aggregate reporting, literature surveillance, signal management, regulatory submissions, and Safety Management Plans. It also monitors service performance and project financials, supports audits and inspections, and ensures compliance with applicable regulations and client requirements. The role is listed at 40–45 hours per week and involves travel of less than 15%. It is eligible for hire in select U.S. locations. The stated anticipated base salary range is $120,000–$135,000, applicable to U.S. locations; compensation depends on relevant experience, qualifications, skills, and geographic location. EVERSANA states that it provides competitive salaries and benefits, with further benefits information available on its careers website.

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 ensuring customer satisfaction.
Use project management principles to plan, track, and drive delivery of milestones, risks, dependencies, and action items.
Lead governance meetings, operational reviews, status meetings, executive reviews, and client communications.
Proactively 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 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 bias management.
Perform other duties as assigned.