Assistant/Associate Director, Pharmacovigilance Quality Assurance

📋 Description

• Lead QA activities for pharmacovigilance quality systems globally
• Audit programs across clinical safety and post-market PV
• Support inspections, CAPAs, change controls, and quality docs
• Provide QA guidance to cross-functional teams
• Monitor regulatory intelligence and evolving PV requirements
• Travel as needed, including occasional short-notice trips

🎯 Requirements

• Bachelor’s degree with 8+ years, Master’s 6+ years, or PhD 3+ years for Assistant Director; higher
• Experience in GVP QA, clinical safety, PV or related life sciences
• Strong PV audit experience (internal, partner, service provider)
• Knowledge of global PV regulations (FDA/EMA), ICH, GCP
• Experience with regulatory inspections and readiness
• Understanding of SOPs, CAPAs, deviations, change controls, QA docs

🎁 Benefits

• Competitive salary: Assistant Director $121,205 – $162,726; Associate Director $138,908 – $196,548
• Fully remote work opportunity within the United States
• Comprehensive benefits package
• Opportunities to contribute to meaningful healthcare solutions
• Collaborative environment with cross-functional teams