Pharmacovigilance Project Director

THE POSITION:
This position serves as the primary client-facing pharmacovigilance director responsible for strategic oversight, operational governance, and delivery excellence across assigned client programs. The role provides leadership across pharmacovigilance operations, client governance, inspection readiness, regulatory compliance, and service delivery while ensuring successful execution of project milestones and achievement of client objectives.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by
Serve as the primary point of contact for assigned clients, building trusted relationships and ensuring a high level of customer satisfaction.
Utilize project management principles to plan, track, and drive delivery of milestones, risks, dependencies, and action items.
Lead governance meetings, operational reviews, and client communications.
Lead governance forums, status meetings, and executive reviews, providing clear communication on project progress and key decisions.
Proactively identify, manage, and resolve client concerns, risks, and escalations to ensure successful project outcomes.
Coordinate cross-functional teams to ensure alignment, accountability, and timely execution of client commitments.
Provide oversight of case processing, aggregate reporting, literature surveillance, signal management, and regulatory submissions.
Drive development and maintenance of Safety Management Plans.
Drive service delivery excellence through continuous monitoring of KPIs, quality metrics, and client feedback, ensuring contractual and operational expectations are met or exceeded.
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 a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias.
All other duties as assigned
EXPECTATIONS OF THE JOB:
Travel (Less than 15%)
Hours (40-45 Hours per week)
The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.
MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:
The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.
Education bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related discipline.
Experience and/or Training
10+ years of pharmacovigilance experience.
5+ years of client-facing project leadership experience.
Strong knowledge of FDA, EMA, ICH, and global PV 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.
PREFERRED QUALIFICATIONS:
Education Advanced degree in Life Sciences, Pharmacy, Nursing, or related discipline.
Experience and/or Training
CRO or pharmacovigilance services experience.
Experience managing pharmaceutical and biotechnology clients.
PMP certification preferred.
Experience with project management tools.
Demonstrated record of client satisfaction and operational excellence.
PHYSICAL/MENTAL DEMANDS AND WORKING ENVIRONMENT:
The physical and mental requirements along with the work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.
Office: While performing the essential functions of this job the employee is frequently required to reach, grasp, stand and/or sit for long periods of time (up to 90% of the shift), walk, talk and hear; occasionally required to lift and/or move up to 25 pounds. The noise level in the work environment is usually moderately quiet, with frequent interruptions and multiple demands.

Employment type
Full-time

Work arrangement
Yes