Safety & PV Specialist II

Enters information into PVG quality and tracking systems for receipt and tracking ICSR. Processes ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans. Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. Enters data into safety database. Codes events, medical history, concomitant medications and tests. Compiles complete narrative summaries. Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved. Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements. Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases.