Drug Safety Specialist III

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.