Senior Associate - Medical review Physicain

📋 Description

• Perform medical review of ICSRs with emphasis on seriousness, expectedness and causality while
• Review ICSRs from sources such as spontaneous, literature, regulatory authorities, solicited and
• Support triage of cases, determine seriousness and relatedness across products.
• Verify adverse event selections, assign MedDRA codes, assess labeling and narratives.
• Maintain PV expertise and knowledge of international safety regulations and guidelines.
• Provide medical guidance to data entry and quality reviewers to resolve queries and improve

🎯 Requirements

• MBBS/MD with 2-4 years of experience as Medical Reviewer for ICSRs.
• Thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR and other regulatory requirements.
• Training and mentoring skills (GVP concepts and medical aspects).
• Hands-on experience with MS Office (Outlook, Excel, Word, PowerPoint).

🎁 Benefits