Pharmacovigilance Project Director

🔥 12 hours ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $120k - $135k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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EVERSANA

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

💼 Consulting

🏥 Healthcare

⚕️ Healthcare Insurance

Consulting • Healthcare • Healthcare Insurance

EVERSANA is a comprehensive service provider focused on integrated commercial solutions for the life sciences industry. The company offers a wide range of services including advisory and management consulting, regulatory consulting, patient services, market access strategies, pricing and revenue management, medical affairs, and digital transformation. EVERSANA is known for its expertise in drug commercialization, enabling companies to effectively launch and manage pharmaceutical products. With a platform powered by data and analytics, EVERSANA addresses challenges related to drug pricing, market access, patient adherence, and product delivery, helping companies optimize their commercial strategies and enhance patient outcomes. The company emphasizes innovation and has been recognized for its use of AI and data analytics within the life sciences sector.

📋 Description

• Serve as the primary point of contact for assigned clients • Build trusted client relationships and ensure high customer satisfaction • Plan, track, and drive delivery of milestones, risks, dependencies, and action items • Lead governance meetings, operational reviews, status meetings, client communications, and executive reviews • Identify, manage, and resolve client concerns, risks, and escalations • Coordinate cross-functional teams for alignment, accountability, and timely execution • Oversee case processing, aggregate reporting, literature surveillance, signal management, and regulatory submissions • Develop and maintain Safety Management Plans • Monitor KPIs, quality metrics, and client feedback to drive service delivery excellence • Ensure compliance with FDA, EMA, ICH, and client-specific requirements • Support audits, inspections, CAPA management, and regulatory inquiries • Monitor billing, invoicing, resource utilization, and budget performance • Demonstrate commitment to diversity, equity, and inclusion • Perform other duties as assigned

🎯 Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related discipline • 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 • Less than 15% travel • 40–45 hours per week • Advanced degree in Life Sciences, Pharmacy, Nursing, or related discipline preferred • CRO or pharmacovigilance services experience preferred • Experience managing pharmaceutical and biotechnology clients preferred • PMP certification preferred • Experience with project management tools preferred • Demonstrated record of client satisfaction and operational excellence preferred

🏖️ Benefits

• Competitive salary and benefits • Remote work option • Reasonable accommodations during the hiring process • Diversity, equity, and inclusion commitment