Medical Reviewer

Responsibilities:

• Perform medical review of Individual Case Safety Reports (ICSRs) for clinical trial and/or post-marketing cases.
• Review and assess the seriousness, causality, expectedness/listenedness, and medical relevance of adverse events.
• Review case narratives, medical history, laboratory data, concomitant medications, and source documents.
• Ensure appropriate MedDRA coding and accurate medical assessment of AE/SAE cases.
• Handle serious/non-serious cases, SUSARs, follow-ups, and case quality reviews.
• Support signal detection, safety surveillance, and risk/benefit assessment, as applicable.
• Ensure cases are processed according to applicable SOPs, ICH/GVP guidelines, and regulatory timelines.
• Collaborate with case-processing, safety, and cross-functional teams to resolve medical queries and maintain case quality.

Requirements:

• Qualification: MBBS / MD - Mandatory.
• Experience: 2+ years in pharmacovigilance, with a minimum of 1 year of hands-on ICSR experience.
• Mandatory Skills: Pharmacovigilance, Medical Review, ICSR, Drug Safety, AE/SAE Review, Causality Assessment, Seriousness Assessment, Expectedness/Listedness, MedDRA, and Narrative Review.
• Preferred: Exposure to Oracle Argus / ARISg / other global safety databases, clinical trial safety, or post-marketing safety.
• Important: Candidates with only clinical/hospital experience or only PV training/internship without hands-on ICSR/PV experience will not be considered. MBBS/MD is mandatory.