Job Title: Medical Reviewer - ICSR

Job Role

Responsible for medical review and assessment of seriousness, causality and labelling of adverse events within agreed timeframes and to a high standard of accuracy, in compliance with Client standard operating procedures and global regulatory requirements .

Responsibilities

• Prioritize medical review for Individual case safety report (ICSRs) in accordance with Client Guidelines, Regulatory due date and turn around me (TAT) service level agreement (SLAs) and key performance indicator (KPIs).
• Verify and confirm on the selection of adverse events, appropriate MedDRA coding, seriousness, labeling, causality of adverse events and provide a company causality comment as per client SOP.
• Review the source documents and narrative to assure medical accuracy pertaining to the case is appropriate and entered Global Safety Database.
• Write company causality comment and route the case to applicable workflow as per Client SOPs
• Constantly update domain and operations skills as per the changing client requirements by reading the updated version of SOPs




• Lead the training of internal and cross-functional team members.
• Actively involved in case discussion with client and provide the valuable inputs to the team.
• Confirm and advise on the medical assessment queries from case processing associate, literature reviewers, quality reviewers and triage associates.
• Validate data consistency and update the relevant database fields for any changes as needed in accordance with Client SOPs
• Determine if any additional information is needed for clarification, or if any follow-up is necessary, and take all relevant steps to obtain any additional/missing information as stated in the relevant Client SOP.
• Consult global safety physician for additional inputs on the case as required by client SOP.
• Create action items in global safety database to ensure case details are sufficient for medical evaluation and route the case back for updating as per Client SOP.

Contact Person: Brindha Kamaraj

Email: [email protected]

📌 Medical Reviewer ICSR (Pharmacovigilance) - Bangalore & Chennai
🏢 Golden Opportunities
📍 Chennai