岗位职责：
1.支持/管理药物警戒相关标准操作规程(SOPs)/标准操作指导(SOIs)，及时确保其符合国家法规和公司内部规程。
Support/Manage pharmacovigilance related Standard Operation Procedure (SOPs)/Standard Operation Instruction (SOIs) to ensure it is in line with national regulations and company internal procedures on a timely basis.
2.支持/维护本地药物警戒体系主文件，并保持更新。
Support/Maintain local PSMF and keep it updated as appropriate.
3.为相关外部和内部员工安排药物警戒培训，准备培训材料并维护培训文件。
Arrange pharmacovigilance training to relevant external and internal staffs, prepare the training materials and maintain the training documentation.
4.支持/执行本地药物警戒活动质量控制，如ICSR提交、PSUR/PBRER/DSUR提交等。
Support/Perform quality control of local pharmacovigilance activities, such as ICSR submission, PSUR/PBRER/DSUR submission etc.
5.为相关职能部门提供支持，确保与第三方签署的本地协议/合同符合国家法规和公司内部规程的药物警戒要求（如果预计第三方因其服务性质会接收不良事件报告）。
Provide support to relevant functions to ensure local agreements/contract with third party can meet the pharmacovigilance requirement of national regulations and company internal procedures if the third party is expected to receive adverse event reports due to the nature of their services.
6.监测本地药物警戒相关法规。
Monitoring of local pharmacovigilance regulation.
7.支持/参与稽查、检查。
Support/contribute to audits, inspections.
8.执行直线经理分配的其他药物警戒活动的任务。
Implement other pharmacovigilance activities responsibilities assigned by LM.
9. 支持科负责人指导团队员工工作。
Support section leader to mentor team members.
资历要求：