Drug Safety Scientist - ICSR & Regulatory Reporting Lead
Jobtailor
Jobtailor is seeking a Health Safety Specialist to support Drug Safety operations in Clayton, NC. You will assist Case Owners with queries, review validation processes, and supervise Drug Safety Coordinators to ensure accurate ICSR submissions and reconciliations. This role requires a BS/MS in health science fields with hands-on safety database experience, strong analytical skills, and proficiency with regulatory reporting and computer systems. #J-18808-Ljbffr Jobtailor
Vacancy posted 1 day ago
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