ICSR Medical Review Specialist

About Alkem

Alkem Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, that manufactures and sells pharmaceutical generics, formulations and nutraceuticals in India and globally over 50 countries. We have consistently been ranked amongst the top five pharmaceutical companies in India. Our portfolio includes illustrious brands like Clavam, Pan, Pan-D, and Taxim-O, which feature amongst the top 50 pharmaceutical brands in India.

Role & responsibilities :

• ICSR Medical Assessment : Conduct the medical review of Individual Case Safety Reports (ICSRs) from all sources.
• Causality & Seriousness : Determine the final company causality assessment, seriousness, and expectedness of all reported adverse events.
• Expedited Review : Prioritize and perform urgent expedited case reviews to ensure timely reporting compliance.
• Final Quality Check : Execute the Post-Processing Quality Check (PPQC) on finalized ICSRs to verify data integrity and accuracy.
• Literature Review : Perform PPQC on literature abstracts to ensure the correct extraction and medical classification of safety data from publications.
• Safety Documentation : Review and approve the medical summary and narrative of case reports for clarity and accuracy.
• Medical Information Call Center (MICC) Triage & Review : Provide safety assessment and review for cases originating from MICC.
• Regulatory Compliance : Ensure all medical review activities comply with global regulatory requirements (e.G., FDA, EMA, ICH).

Education background : MBBS

Preferred Experience : 2-4 year in medical review of ICSRs.