Medical Reviewer/Pharmacovigilance

Qualification: MBBS

Experience: 0 to 2 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.