Previous Job
Previous
Drug Safety Specialist III
Ref No.: 18-07870
Location: San Francisco, California
Ensures compliance with standard operating procedures, Food and Drug Administration and ICH guidelines and regulations, and global regulations for the reporting of adverse events to regulatory agencies. Insures the uniform and timely processing of adverse event reports. Develops and prepares reports for company management as well as external regulatory agencies. May work with data management in the ongoing development of case report forms for clinical trials and maintenance of databases.

Performing complete data entry of serious adverse events received from clinical trials, according to the Nektar workflow processes and standard operating procedures. Generate 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. Draft 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 Nektar Drug Safety person. Communicate or notify Nektar drug safety staff of issues related to case processing/coding, safety database and/or any other issues that impact case processing quality or timelines. Maintain and track all serious adverse events reported from Nektar sponsored clinical trials for case processing relative to their priorities and submission deadlines. Support Drug Safety Department initiatives on ad hoc (as needed) basis. Adherence to global regulatory regulations and reporting timelines for all expedited serious adverse events. Maintain or track annual and/or periodic Pharmacovigilance regulatory submissions in USA and globally. Ensure compliance with Nektar’s SOPs.