Senior Medical Data and Safety Review Physician
Core
Senior physician responsible for medical data review, safety case processing, and ensuring medical/scientific plausibility in clinical trials.
Role type
Senior Medical Data and Safety Review Physician
Builds
Safety reports, data review plans, and medical assessments for clinical trials
Domain
Clinical Research / Pharmacovigilance
Required skills
Medical degree, medical license, 5+ years clinical practice, 3+ years medical data/safety review, 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
Responsibilities
Write Medical Data Review Plan and Guide, review data listings and patient profiles (AEs, labs, vitals), assess SAEs (causality, seriousness), compose Safety Trend Analysis Reports (STAR), conduct in-stream data trend analysis, mentor team members
Seniority
Senior, hands-on IC
