Job Description

Qualification: MBBS Experience: 1 to 3 years Previous experience in medical review of ICSRs. Knowledge of safety databases, such as Argus, ARISg, or similar systems. Familiarity with medical coding dictionaries (e.g., MedDRA) and adverse event reporting standards (e.g., ICH E2B). Strong attention to detail and ability to work with complex medical data. Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders. Key Responsibilities: Individual Case Safety Reports (ICSRs) Review: Conduct thorough and objective medical review of ICSRs received from various sources, including clinical trials, spontaneous reports, and literature. Assess the medical relevance and causality of adverse events reported in ICSRs. Identify and evaluate potential safety signals and perform appropriate follow-up actions as necessary. Ensure accurate and timely reporting of serious and non-serious adverse events to regulatory authorities.