Medical Reviewer Consultant
Core
Perform medical review of non-serious and serious Individual Case Safety Reports (ICSRs) to assess seriousness, expectedness, causality, and narrative quality for pharmaceutical and medical device partners.
Role type
Medical Reviewer Consultant (Pharmacovigilance)
Builds
Safety databases and regulatory compliance reports for global pharmaceutical clients
Domain
Healthcare / Pharmacovigilance / Regulatory Affairs
Deliverable
client delivery
Required skills
Medical review of ICSRs, GVP module knowledge, MedDRA coding, therapeutic area expertise (Oncology, Respiratory, Immunology, Neuroscience, Rare diseases), case triage, regulatory guideline interpretation (ICH-GCP, 21 CFR), 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