Pharmacovigilance Project Director

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

📋 Description

• Act as the main contact for designated clients

• Foster trustworthy relationships with clients and ensure exceptional customer satisfaction

• Organize, monitor, and drive the delivery of milestones, risks, dependencies, and action items

• Conduct governance meetings, operational reviews, status updates, client communications, and executive assessments

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

• Coordinate with cross-functional teams to ensure 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 quality

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

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

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

• Show dedication to diversity, equity, and inclusion

• Execute other responsibilities as assigned

⛳️ Requirements

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

• Over 10 years of experience in pharmacovigilance

• At least 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

• Proven experience overseeing comprehensive pharmacovigilance services

• Exceptional communication, stakeholder management, and presentation abilities

• Capable of managing multiple complex client programs and priorities

• Willingness to travel less than 15% of the time

• Availability for 40–45 hours per week

• Advanced degree in Life Sciences, Pharmacy, Nursing, or a related field is preferred

• Experience in CRO or pharmacovigilance services is preferred

• Experience managing pharmaceutical and biotechnology clients is preferred

• PMP certification is preferred

• Familiarity with project management tools is preferred

• Proven track record of client satisfaction and operational excellence is preferred

🏝️ Benefits

• Competitive salary and benefits package

• Option for remote work

• Reasonable accommodations provided during the hiring process

• Commitment to diversity, equity, and inclusion