Senior Associate, Medical Review Physician

About the role

The Senior Associate, Medical Review Physician will conduct comprehensive medical reviews of individual case safety reports (ICSRs) across multiple therapeutic areas. This role ensures high‑quality, compliant assessments of seriousness, expectedness, causality, and narrative while supporting process improvements and mentorship within the safety team.

Key responsibilities

• Perform medical review of non‑serious and serious ICSR cases, focusing on seriousness, expectedness, causality, and narrative quality.
• Review ICSR sources including spontaneous reports, literature, regulatory authority submissions, solicited reports, and clinical trials.
• Support case triage, determine seriousness and relatedness, and assign appropriate MedDRA codes.
• Verify adverse event selection, assess labeling, and draft review narratives.
• Maintain up‑to‑date knowledge of product portfolios and safety profiles across therapeutic areas such as oncology, respiratory, immunology, neuroscience, and rare diseases.
• Participate in quality control implementation and process‑improvement initiatives.
• Provide medical guidance to data entry associates and quality reviewers, resolving queries and case issues.
• Ensure timely completion of medical review activities in the safety database to meet service level agreements and regulatory timelines.
• Assist in training and mentoring of case processing and medical review personnel.

Required profile

• Medical physician with a minimum of 2 years experience as a medical reviewer of ICSR cases.
• Thorough knowledge of ICH‑GCP, relevant GVP modules, 21 CFR guidelines, and other international safety regulations.
• Experience across multiple therapeutic areas (e.g., oncology, respiratory, immunology, neuroscience, rare diseases).
• Strong training and mentoring abilities for GVP concepts and medical aspects.

Required skills

• Proficiency with Microsoft Office applications (Outlook, Excel, Word, PowerPoint).