Description

You will perform medical review of individual case safety reports (ICSRs) across multiple therapeutic areas, ensuring quality compliance and adherence to regulatory timelines. You will also provide medical guidance, participate in process improvements, and assist in training and mentoring case processing personnel.

Requirements

• MBBS/MD with at least 2 years of experience as Medical Reviewer for ICSRs
• Thorough knowledge of ICH-GCP, relevant GVP modules, 21 CFR guidelines
• Training and mentoring skills in GVP concepts and medical aspects
• Proficient in MS Office applications (Outlook, Excel, Word, PowerPoint)
• Must be able to write and speak Japanese

Responsibilities

• Perform medical review of non-serious and serious ICSRs focusing on seriousness, expectedness, causality, and narrative
• Review and verify adverse event selection, assign MedDRA codes, assess labelling, and review narrative
• Support triage of cases and determine seriousness and relatedness
• Provide medical guidance to data entry associates and quality reviewers
• Maintain expertise in pharmacovigilance and international safety regulations