Awareness and understanding of relevant GVP modules.
Medical review of non-serious and serious ICSRs focusing on seriousness, causality.
Review ICSRs from spontaneous, literature, regulatory authority, solicited and trials.
Experience across multiple therapeutic areas (Oncology, Respiratory, Immunology, neuroscience).
Support triage of cases and determine seriousness and relatedness across products.
Review and verify selection of adverse events, assign MedDRA codes, review narratives.

🎯 Requirements

MBBS/MD with 2-4 years of experience as Medical Reviewer for ICSRs.
Thorough knowledge of ICH-GCP, GVP modules, 21 CFR and regulatory requirements.
Training and mentoring skills in GVP concepts and medical aspects.
Hands-on experience with MS Office applications (Outlook, Excel, Word, PowerPoint).

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