1.藥品安全性監視計畫之執行及嚴重不良反應通報。
Execution of drug safety surveillance program and reporting of serious adverse events.
2.藥品/醫材上市後變更及展延送件
Submission of renewal and variations for drugs and medical devices
3.跨部門溝通
Work closely with project teams.
4.送件資料歸檔及維護
Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted.
5.其他主管上級交辦事項
Complete assigned tasks