Pharmacovigilance Project Director

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Act as the main client-facing pharmacovigilance director for designated client programs

• Provide strategic direction, operational governance, and ensure delivery excellence

• Be the primary contact for assigned clients and cultivate trusted relationships

• Organize, monitor, and propel the achievement of milestones, risks, dependencies, and action items

• Lead governance meetings, operational reviews, status updates, client communications, and executive evaluations

• Identify, manage, and address client concerns, risks, and escalations

• Facilitate coordination among cross-functional teams for alignment, accountability, and timely execution

• Supervise case processing, aggregate reporting, literature surveillance, signal management, and regulatory submissions

• Create and uphold Safety Management Plans

• Track KPIs, quality metrics, and client feedback to enhance service delivery excellence

• Ensure adherence to FDA, EMA, ICH, and client-specific requirements

• Assist with audits, inspections, CAPA management, and regulatory inquiries

• Oversee billing, invoicing, resource utilization, and budget performance

• Show a strong commitment to diversity, equity, and inclusion

• Carry out other assigned duties

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field

• More than 10 years of experience in pharmacovigilance

• Over 5 years of experience in client-facing project leadership

• In-depth knowledge of FDA, EMA, ICH, and global pharmacovigilance regulations

• Experience in supporting inspections and audits

• Experience managing end-to-end pharmacovigilance services

• Exceptional communication, stakeholder management, and presentation abilities

• Capability to manage multiple complex client programs and priorities

• Travel limited to less than 15%

• Expected working hours: 40–45 hours per week

• An advanced degree in Life Sciences, Pharmacy, Nursing, or a related discipline is preferred

• Experience in a CRO or pharmacovigilance services is preferred

• Familiarity with managing pharmaceutical and biotechnology clients is preferred

• PMP certification is preferred

• Experience with project management tools is preferred

• A proven track record of client satisfaction and operational excellence is preferred

🏝️ Benefits

• Competitive salaries and comprehensive benefits

• Option for remote work

• Equal Opportunity Employer

• Reasonable accommodation during the hiring process for qualified applicants with disabilities