●PV system introduction
●Pharmacovigilance Audits
●Training
●Literature search
●Case management,
●Draft/Review PSUR
●Draft Annual Report
●Signal detection
●Specification and update instructions
●Product Medical Information
●Support Call center
●Preparation: Review protocol; Review investigator branch; Review CRF; Draft safety management plan; database setup
●Case management
●Draft/Review DSUR
●Independent Data Monitoring Committee （IDMC）
●Signal detection
●Draft/Review risk management plan
●Specification instructions
●Investigator handbook writing and updating