Associate Director Safety & Pharmacovigilance

About the role & responsibilities
• Act as primary client interface for Safety & Pharmacovigilance services
• Lead and manage Safety and PV teams across programs
• Oversee delivery as per Safety Management Plans and contracted scope
• Monitor quality, KPIs, productivity and drive performance improvement
• Ensure timely safety reporting and regulatory compliance
• Review study budgets, forecasts and invoicing
• Serve as escalation point for sponsors
• Lead PV projects and inspections readiness activities
• Review protocols, CRFs, SAE forms and safety documents
• Develop and approve SOPs, WIs and process improvements
• Support business development, bids and proposal reviews
• Provide PV training and expert consultation

Qualification
• Bachelor’s degree in Life Sciences / Pharmacy / Nursing / Healthcare

Experience
• Extensive leadership experience in Safety & Pharmacovigilance
• CRO exposure preferred

Skills
• ICH-GCP and GVP regulations
• Safety reporting operations
• People and project management
• Budgeting and financial oversight
• Strong stakeholder communication

About the company
• Syneos Health is a global biopharmaceutical solutions organization working on most FDA-approved novel drugs