Roles & Responsibilities
• Process, triage, and track ICSRs as per SOPs and safety plans
• Enter safety data into databases and perform MedDRA coding
• Review cases for completeness, accuracy, and regulatory reportability
• Prepare case narratives and manage follow-up queries
• Support expedited safety reporting and literature case processing
• Identify and manage duplicate cases
• Support xEVMPD, SPOR/IDMP, and drug dictionary activities
• Ensure TMF and PV system documentation compliance
• Participate in audits and maintain regulatory compliance
Qualification
• B.Pharm / M.Pharm / PharmD / BDS
Experience
• Minimum 2 years in Pharmacovigilance or Safety Case Processing
Skills
• Strong PV and safety reporting knowledge
• Experience with safety databases and medical terminology
• Knowledge of ICH-GCP, GVP, and global PV regulations
• Good communication, documentation, and time-management skills
About the Organisation
Syneos Health® is a global biopharmaceutical solutions organization supporting clinical development, medical affairs, and commercialization. With operations across 110 countries, Syneos Health is recognized for its patient-centric approach, regulatory expertise, and strong career development culture.
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