1. Handling and submission of individual safety reports such as SAE

2. Processing and distribution of SUSAR reports

3. Development and training of Clinical Trial Safety Management Plan (SMP)

4. Writing of Security Update Report (DSUR) during R&D period

5. Writing of Clinical Research Drug Risk Control Plan (RCP) and Risk Management Plan (RMP)

6. Development of regular safety information summary and analysis plan for clinical research drugs and report writing

7. Local proxy submission of overseas cross reporting

1. 24-hour hotline and regular literature search;

2. Handling of individual safety reports after drug launch (including feedback data from the direct reporting system and spontaneous reports)

3. Writing PSUR and PBRER

1. Consultation on drug surveillance system (main documents, relevant SOPs);

2. Drug surveillance inspection