Awareness and understanding of relevant GVP modules.
Medical review of ICSRs focusing on seriousness, causality, narrative, and compliance.
Review ICSRs from spontaneous, literature, regulatory authority, solicited and trials.
Experience across Oncology, Respiratory, Immunology, Neuroscience, Rare diseases.
Triage cases; determine seriousness and relatedness across products.
Review adverse events; assign MedDRA codes; assess labeling and narrative.

🎯 Requirements

Medical Physician with at least 2 years as Medical Reviewer for ICSRs.
Thorough knowledge of ICH-GCP, GVP module, 21 CFR guidelines and regulatory requirements.
Training and mentoring skills in GVP concepts and medical aspects.
Hands-on experience with MS Office (Outlook, Excel, Word, PowerPoint).

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