Scientist - 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 for pharmaceutical and medical device partners.
Role type
Medical Review Physician (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, Therapeutic area expertise (Oncology, Respiratory, Immunology, Neuroscience, Rare diseases), GVP module knowledge, MedDRA coding, Adverse event selection, Regulatory guideline interpretation (ICH-GCP, 21 CFR), Case triage and seriousness determination, Product portfolio knowledge, Process improvement, Team mentoring
Preferred skills
None stated
Technologies
MS Office (Outlook, Excel, Word, PowerPoint), Safety databases
Responsibilities
Review and verify adverse events from source documents, assign MedDRA codes, assess labelling, provide medical guidance to data entry associates, resolve case issues, coordinate with client therapeutic teams, complete MR activities within SLAs, provide feedback on discrepancies, assist in training personnel, adapt to client conventions, perform ad-hoc tasks
Seniority
Mid-level (2-4 years experience)
