博 王

·  Contributes to vendor selection. Cooperates with other functions to ensure the needed PV requirements are in contacts of the vendors. ·  Provides vendor oversight (compliance and quality) and contract management. ·  Ensures the accurate and timely reporting of individual case safety reports (ICSRs) and expedited safety reports originating from clinical studies, in compliance with internal timeframe and regulatory requirements, in cooperation with PV vendors. ·  Oversees process flow and interacts with other functions to identify process improvement strategies and communicate project status updates. ·  Develops, reviews and updates PV related SOPs, forms and template in line with regulations of regular authorities and company internal requirements. ·  Provide PV training to internal and external stakeholders. ·  Prepares for and participates in regulatory inspections/audits and contributes to the development and implementation of CAPA.

1. Management of Individual Case Safety Report (ICSR) from all relevant sources (solicited and unsolicited sources). 2. Management of Aggregate Reports 3. Vendor (e.g. Case Processing, PSP, Literature screening and Translation) oversight to ensure alignment with company SOPs and China regulations. 4. Study (Roche-Sponsored Studies, Investigator Initiated Study, Compassionate Use Program) oversight, include but not limited to protocol review, SDEA review, perform CTV, CTA maintenance and GCP (new version) implementation.

1. Responsible for routine PV operation tasks and vendor management. 2. Submit ICSR with compliance with local regulation and SOP requirement. 3. Continuously improve the process and procedure to optimize the collaboration with PV vendors and ensure the compliance and quality.

1. Perform RA compliance monitoring via BRAIN (Bayer Regulatory Affairs Information system) to ensure target compliance rate. 2. Provide cross team discussion (e.g. global labeling, local RA, regional head) on compliance issues. 3. Data quality check on registration and all variations (PSUR, CCDS, CMC and renewal) in BRAIN. 4. Support HA inspection or internal audit by compliance check in BRAIN. 5. Coordinate on archiving labeling related document (original dispatch, country dependency, waiver and deviation). 6. Provide compliance & quality report to regional head and functional head within scheduled timeline. 7. Coordinate maintaining the whole product life circle in SYNAPS.

1. 在规定时限内将不良反应报告录入公司内部数据库， 并发送至公司总部 2. 确保数据的完整性，准确性和内部数据库的一致性。 3. 根据标准工作流程以及美国食品药品监督管理局的政策法规，决定所收到的有关默克公司研究或销售产品的不良反应报告严重程度。 4. 就药品安全以及GCP相关问题与美国总部同事进行沟通。 5. 对新员工进行培训和指导，并提供支持和帮助。