Sr Safety & PV Specialist - Literature Review & CAPA Management

Roles & Responsibilities
• Conduct systematic and ad-hoc literature searches using global biomedical databases (PubMed, Embase, Medline) for ICSR identification
• Extract, summarize, and report relevant safety information from scientific literature
• Develop, execute, and validate literature search strategies, including local literature reviews
• Support PV quality activities such as quality trend analysis, deviation management, Root Cause Analysis (RCA), and CAPA management
• Participate in ICSR processing activities including triaging, MedDRA/WHO-DD coding, data entry, and narrative writing
• Ensure compliance with global and local pharmacovigilance regulations (ICH GCP, GVP)
• Assist in preparation and maintenance of Safety Management Plans and support internal project review meetings
• Provide training to investigators on ICSR reporting requirements
• Support regulatory audits and inspections
• Maintain accurate and compliant documentation in TMF and PSMF

Qualification
• B.Pharm / M.Pharm / PharmD / BDS / BMS

Experience
• Minimum 2+ years of experience in literature review, pharmacovigilance quality review, and CAPA management
• Experience in clinical trial safety (Phase II–IV) and/or post-marketing safety

Skills
• Strong knowledge of pharmacovigilance processes, ICSR management, and safety databases
• Good understanding of ICH GCP, GVP, and global PV regulations
• Proficiency in Microsoft Office Suite and PV systems
• Excellent communication, presentation, and documentation skills
• Detail-oriented with strong analytical ability and the capacity to work independently or in a team

About the Organization
Syneos Health is a leading global biopharmaceutical solutions company that integrates clinical development, medical affairs, and commercial services. The company partners with customers to accelerate product development and deliver therapies that improve patient outcomes worldwide.