Awareness and understanding of relevant GVP modules.
Review non-serious and serious ICSRs focusing on seriousness, causality and narrative.
Review ICSRs from spontaneous, literature, regulatory, solicited and trials.
Acquire and maintain knowledge of product portfolio and safety profiles.
Triage cases and determine seriousness and relatedness across products.
Verify adverse events, assign MedDRA codes, assess labeling.

🎯 Requirements

MBBS/MD with 2-4 years of experience as Medical Reviewer for ICSRs.
Strong knowledge of ICH-GCP, GVP, 21 CFR, and regulatory requirements.
Training and mentoring skills in GVP concepts and medical aspects.
Hands-on MS Office experience (Outlook, Excel, Word, PowerPoint).
Experience with safety databases and PV processes.
Ability to work with cross-functional teams and meet timelines.

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