Drug Safety Associate

该职位来源于猎聘 Responsibilities and Accountabilities: 1、Individual Case Safety Report (ICSR) Management: Receive, triage and process initial and follow up adverse event reports from multiple sources (clinical trials, post-marketing, literature, regulatory authorities, etc.)  Perform quality review of cases for completeness, consistency, and compliance.  Ensure timely submission to PV Headquarter and Competent Authorities  Conduct data entry in safety database. Perform reconciliation activities. Perform filing and archiving activities.2、Establishment And Enhancement Of The ICSR Management Procedures Support the optimization of ICSR management initiatives. Collaborate with vendor and Headquarter functions to ensure quality and compliance and drive process efficiency.  Conduct E2B(R3) and gateway management and transmission issue solutions.3、Manage or support other affiliate PV activities including but not limited to:  Self-assessment, audit, and inspection Aggregate reporting Business partner and PV agreement management Training Quality document management Preferred Qualifications: 1、 Global database management experiences2、 Project management experiences3、 Vendor management experiences