Principal Safety & PV Specialist

Roles & Responsibilities
• Conduct systematic and ad-hoc literature searches in Embase, PubMed, and Medline for ICSR identification
• Create, validate, and optimize pharmacovigilance literature search strategies
• Extract and summarize safety-relevant information from global and local literature
• Manage end-to-end literature case processing (ICSRs)
• Perform case triage, data entry, MedDRA and WHO-DD coding, and narrative writing
• Ensure timely and compliant expedited and periodic safety reporting
• Prepare, review, and maintain Safety Management Plans (SMPs)
• Coordinate workflow, task allocation, and delivery of program milestones
• Support trend analysis, signal detection, and safety data reconciliation
• Act as Subject Matter Expert (SME) and mentor PV team members
• Support audits, inspections, and investigator training activities
• Ensure compliance with ICH-GCP, GVP, SOPs, and global PV regulations

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

Experience
• Minimum 8 years of experience in literature case processing within pharmacovigilance
• Proven experience in team handling, mentoring, or lead roles

Skills
• Strong expertise in ICSR processing and safety databases
• In-depth knowledge of clinical trial (Phase II–IV) and post-marketing safety
• Thorough understanding of ICH-GCP, GVP, and global pharmacovigilance regulations
• Proficiency in MS Word, Excel, PowerPoint, Outlook, and Visio
• Excellent communication, organizational, and decision-making skills
• High attention to detail with ability to work under tight timelines

About the Organization
Syneos Health is a leading global biopharmaceutical solutions organization that integrates clinical development and commercialization expertise. Having supported approximately 94% of novel FDA-approved drugs, Syneos Health partners with customers to accelerate the delivery of therapies that improve patient lives worldwide.