工作职责: Responsible for the handling and reporting of ICSRs from Clinical Trial projects (Including but not limited to case processing, submission and distribution, cross reporting, and safety data exchange, etc.). Develop and implement safety management plan of Pharmacovigilance department, performing regular reconciliation, maintaining line listings. Provide support for PV related documents in clinical trials. Responsible for organization/development/quality control/distribution and submission of development safety updated report.