Senior Associate, Medical Review Physician
Core
Perform medical review of non-serious and serious Individual Case Safety Reports (ICSRs) to assess seriousness, expectedness, causality, and narrative quality across multiple therapeutic areas.
Role type
Senior Associate Medical Review Physician
Builds
Safety databases and regulatory compliance reports for pharmaceutical products
Domain
Life Sciences / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Medical Physician qualification, ICSR medical review, therapeutic area expertise (Oncology, Respiratory, Immunology, Neuroscience, Rare diseases), MedDRA coding, ICH-GCP knowledge, 21 CFR guidelines, GVP modules, MS Office proficiency
Preferred skills
Process improvement, training and mentoring, cross-functional coordination
Technologies
Safety databases, MS Office (Outlook, Excel, Word, PowerPoint)
Responsibilities
Review and verify adverse events from source documents, assign MedDRA codes, assess labelling, provide medical guidance to data entry associates, resolve case issues, complete MR activities within SLAs, assist in training personnel
Seniority
Mid-level, hands-on IC