Sr Safety & PV Specialist Job at Syneos Health in Gurugram / Hyderabad | Jobslly

Role & Responsibilities
• Conduct systematic and ad-hoc literature searches in Embase, PubMed, Medline
• Identify Individual Case Safety Reports (ICSRs) from scientific literature
• Develop and validate pharmacovigilance search strategies
• Perform case triage, data entry, MedDRA/WHODrug coding
• Prepare narratives and ensure regulatory compliance (ICH-GCP, GVP)
• Generate expedited and periodic safety reports
• Support audits, inspections, and TMF/PVSMF documentation
• Act as Subject Matter Expert (SME) and mentor team members

Qualifications & Experience
• B.Pharm, M.Pharm, PharmD, BDS, BMS
• Minimum 5 years of experience in pharmacovigilance, including literature case processing
• Strong knowledge of global and local pharmacovigilance regulations
• Hands-on experience with safety databases
• Expertise in literature surveillance and case processing

About the Company
• Syneos Health is a global leader in biopharmaceutical solutions, working with 94% of FDA-approved novel drugs and offering career growth opportunities for professionals in the field.