We are looking for a Drug Safety Specialist III, working in the Pharmaceuticals & Medical Products industry in Abbeville, California, United States.
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.
The pay we are offering is 50 per hour. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Knowledge in standard operating procedures, Food and Drug Administration and ICH guidelines and regulations
Able to complete data entry to the Nektar workflow processes and standard operating procedures
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.