Ikya Global
Job Description
The Drug Safety Associate supports pharmacovigilance activities by processing and reviewing adverse event reports to ensure patient safety and regulatory compliance.
Key Responsibilities
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Process Individual Case Safety Reports (ICSRs)
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Perform case intake, triage, and data entry
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Code adverse events using MedDRA
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Assess case seriousness and expectedness under guidance
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Ensure timely case submission as per regulatory timelines
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Maintain PV documentation and audit readiness
Skills & Requirements
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Degree in Pharmacy / Life Sciences / Nursing
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Basic knowledge of pharmacovigilance and drug safety
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Familiarity with MedDRA and safety databases (Argus, ArisG) is a plus
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Strong attention to detail and documentation skills
