Tech Stack

Description

You will perform medical review of ICSRs, ensuring compliance with GVP modules and regulatory timelines. You will also support triage, case processing, and provide medical guidance to the team.

Requirements

• Medical Physician with at least 2 years of experience as Medical Reviewer for ICSRs
• Thorough knowledge of ICH-GCP, GVP modules, 21 CFR guidelines
• Training and mentoring skills in GVP concepts
• Hands-on experience with MS Office applications

Responsibilities

• Perform medical review of ICSRs for seriousness, expectedness, and causality
• Support triage of cases and determine seriousness and relatedness
• Acquire and maintain knowledge of product safety profiles
• Provide medical guidance to data entry associates and quality reviewers
• Complete MR activities in safety database within regulatory timelines