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 complete 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 communicates 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.
- Supports Drug Safety Department initiatives on an ad hoc (as needed) basis.
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