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.

Department: Clinical & Medical
Function: Writing/Editing
Experience Level: Mid-Senior Level