Senior Medical Reviewer (Alexion)
Core
Reviewing medical and safety data in late-phase clinical trials to ensure data integrity, completeness, and accuracy for drug development.
Role type
Senior Medical Reviewer (Clinical Data)
Builds
Clinical trial data packages and safety reports for drug development programs.
Domain
Biopharmaceuticals / Clinical Research
Required skills
Medical data review, Safety data analysis, Clinical trial protocols, ICH/GCP guidelines, SAE reporting, Medical coding (MedDRA/WHO DD), Data visualization, Cross-functional collaboration, Mentoring, Quality assurance
Preferred skills
Electronic data capture systems, Query management tools, Medical coding dictionaries, Data analysis programming (Python/R/SAS), Risk-Based Monitoring, Negotiation
Technologies
JReview, JMP Clinical, Elluminate, Spotfire, Microsoft Power Platform, MedDRA, WHO DD, Python, R, SAS
Responsibilities
Review patient-level clinical/safety data and generate queries; Lead quality assurance of deliverables and mentor junior staff; Prepare aggregated data visualizations; Escalate critical findings and adverse events; Support study setup, maintenance, and closure; Develop procedures and training activities.
Seniority
Senior, hands-on IC with mentorship responsibilities