Senior Associate - Medical review Physicain

Overview

Senior Associate Medical Review Physician responsible for medical review of serious and non-serious ICSRs, ensuring quality and regulatory compliance.

What you'll do

• Perform medical review of ICSRs focusing on seriousness, expectedness, causality, and narrative.
• Review and verify appropriate adverse event selection from source documents and assign MedDRA codes.
• Assess labelling and review case narratives; support case triage for seriousness and relatedness.
• Provide medical guidance and expert opinion to case data entry associates and quality reviewers.
• Complete medical review (MR) activities in the safety database within service level agreements and regulatory timelines.
• Feed back errors/discrepancies to case processors and support process improvement activities.
• Assist with training/mentoring and adapt to different client case processing conventions.

What you'll need

• MBBS or MD qualification.
• 2-4 years of experience as a Medical Reviewer for ICSRs.
• Thorough knowledge of ICH-GCP.
• Knowledge of relevant GVP module and 21 CFR guidelines.
• Training and mentoring skills for GVP concepts and medical aspects.
• Hands-on experience with MS Office applications including Outlook, Excel, Word, and PowerPoint.

Details

• Location: Bengaluru.