北京-药物警戒专员（Contract PV）

1. Enters information into ICSR tracking sheet for receipt and submission of safety report. 2. Processes ICSRs according to Standard Operating Procedures (SOPs), Working Instructions (WIs) and safety database user manual  Receives and documents incoming safety report from all sources.  Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability.  Enters data into safety database.  Codes events, medical history, indications of medications, 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. 3. Completes distribution of all required individual expedited and periodic reports for both clinical and postmarketing products within required timeline. 4. Assists in the preparation of the Safety Management Plan. 5. Participates in audit/inspection as required. 6. Ensures all relevant documents are stored appropriately per company SOP. 7. Performs literature search and review. 8. Maintains understanding and compliance with SOPs, WIs, PV related global and local legislation and regulations, ICH guidelines. 9. Coordinates with data management staff concerning SAE reconciliation between the clinical and safety databases. 10. Liaises with partners and other stakeholders regarding safety data collection and reconciliation. 11. Completes other tasks assigned by line manager.