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Drug Safety Specialist III
1 month ago
Description We're looking for a Drug Safety Specialist III , working in Pharmaceuticals and Medical Products industry in Abbeville, California, United States . Job description: Performs complete data entry of serious adverse events received from clinical trials, according to the workflow processes and standard operating procedures. Generates accurate and completes case narratives based on information received as part of source documents including but not limited to, case report forms, hospital admission notes, history and physical (H&P) consult notes, progress notes, lab results, results of diagnostic, radiological and other tests, discharge summaries, death certificate and autopsy results provided by the study sites. Drafts appropriate queries for outstanding information or incomplete data and communicate the queries to study site personnel following review and approval of the queries by a senior Drug Safety person. Communicates or notifies drug safety staff of issues related to case processing/coding, safety database and/or any other issues that impact case processing quality or timelines. Maintains and tracks all serious adverse events reported from sponsored clinical trials for case processing relative to their priorities and submission deadlines. Support Drug Safety Department initiatives on ad hoc (as needed) basis. #J-18808-Ljbffr
