DSP specialist is operational oriented in AE collection, processing, reporting and follow-up of all adverse events (AE) reports for all MCPC products from various sources.
To support DSP Manager in all activities as needed, ensure compliance with MCPC requirements and local regulations requirement.
1.Handle ICSR and any other interested safety cases from all source according to SOP and regulations. Contribute to China GVP and E2B submission implementation in China to make sure compliance with ICH.
2.Aggregate safety management and submission including develop aggregate report for local products and for product regulatory renewal.
3.Manage PV documentation。
4.Provide safety related training to internal and external stakeholder。
5. Liaise with key partners and 3rd party for safety information exchange and safety data reconciliation