Safety & PV Specialist I
About the Role
Role & Responsibilities
• Perform end-to-end ICSR case processing including case booking and triage
• Handle spontaneous, clinical trial and literature safety cases
• Perform accurate medical coding and safety data entry
• Ensure compliance with ICH-GCP guidelines, regulatory standards and SOP requirements
• Work on global safety databases such as Argus, ARIS-G and LifeSphere Multi-Vigilance (LSMV)
• Collaborate with cross-functional pharmacovigilance teams
• Support timely and high-quality safety reporting activities
Qualification
• B.Pharm / M.Pharm
• BDS / BMS / MBBS
(BSc / MSc candidates are not eligible)
Experience
• 2.6 – 4 years of hands-on ICSR case processing experience
Skills
• Strong knowledge of medical terminology
• ICSR processing & triage
• Medical coding and safety database handling
• Knowledge of ICH-GCP and regulatory compliance
• Good written and verbal communication skills
About the Company
Syneos Health is a leading global contract research organization (CRO) providing integrated biopharmaceutical solutions across clinical development, pharmacovigilance, medical affairs and commercialization. The company supports global safety surveillance and regulatory compliance for pharmaceutical and biotechnology products worldwide.
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