Manager, Safety & Pharmacovigilance (ICSR)

About the role & responsibilities

• Lead and manage pharmacovigilance safety teams
• Oversee ICSR case processing, quality and regulatory compliance
• Manage safety projects, deliverables and timelines
• Monitor workload distribution, productivity and performance metrics
• Review safety budgets, expenses and invoicing
• Ensure compliance with GVP, ICH, GCP and global PV regulations
• Support audits, inspections and CAPA activities
• Review clinical protocols, CRFs, SAE forms and safety documentation
• Support SOP development, process improvements and business development

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

Experience
• Minimum 8 years pharmacovigilance experience
• Minimum 5 years people management experience
• CRO experience preferred

Skills
• ICSR management and safety project leadership
• ARGUS / ARISg Safety database expertise
• Advanced MS Excel skills
• SQL / Power BI knowledge (preferred)
• Strong communication, leadership and client management skills

About the company
• Syneos Health is a global biopharmaceutical solutions organization operating in 110+ countries, supporting majority of FDA and EMA approved products