Senior Medical Data and Safety Review Physician
Core
Conduct medical data review and safety case processing to ensure medical/scientific plausibility for clinical trials and standalone safety projects.
Role type
Senior Medical Data and Safety Review Physician
Builds
Medical data review plans, data capture requirements, data listings, patient profiles, Safety Trend Analysis Reports (STAR), and sponsor comments for clinical trials.
Domain
Clinical research / Pharmacovigilance
Required skills
Medical degree, medical license, 5+ years clinical/academic medicine experience, 3+ years medical data/safety review experience, advanced English, MedRA, WhoDrug, Medidata Rave, Inform, Argus Safety, Excel, PowerPoint, Spotfire, J Review
Preferred skills
Specialty medical training or fellowship
Technologies
Medidata Rave, Inform, Argus Safety, Spotfire, J Review, Qlik Sense
Responsibilities
Write Medical Data Review Plan and create protocol-specific Medical Data Review Guide; Provide medical review of data listings and patient profiles including adverse events and labs; Conduct in-stream data trend analysis for data quality and integrity; Assess and code SAEs including causality and seriousness; Compose STAR reports and periodic MDR summary reports.
Seniority
Senior, hands-on IC
