Job description
About the role
Full-time, office-based role in Chennai, supporting end-to-end Individual Case Safety Report (ICSR) processing across clinical trials and post-marketing programs.
Key responsibilities
- Triage ICSRs for validity, completeness, seriousness and reportability; enter data into safety databases.
- Code adverse events, medical histories, tests and medications using MedDRA and WHO Drug dictionaries.
- Write medical narratives, resolve missing-information queries, manage duplicates and review case quality.
- Compile and dispatch safety reports to global regulators, ethics committees and investigators within reporting timelines.
- Validate and electronically submit xEVMPD product records, including indication coding; support SPOR/IDMP data maintenance and manual dictionary recoding.
- Maintain trackers and safety metrics; archive documentation in the Trial Master File and Pharmacovigilance System Master File.
- Screen global and local literature for adverse drug reactions and safety signals; support audits and inspections.
- Apply regulatory intelligence and maintain current knowledge of ICH-GCP, GVP, national mandates and applicable standard operating procedures.
Requirements
- 2.6–4 years of hands-on pharmacovigilance experience covering ICSR processing, narrative writing and safety databases.
- Working knowledge of MedDRA coding conventions and WHO Drug dictionaries.
- Exposure to regulatory submissions, xEVMPD or SPOR/IDMP standards is highly desirable.
- Strong medical terminology, analytical review, documentation accuracy and attention to reporting deadlines.
- Clear written and spoken English; ability to work on-site in Chennai.
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