药物警戒经理/PV经理

职责描述： 1.
Provide safety support for pre-marketing and post-marketing stage. 为药品上市前和上市后阶段提供安全支持。2.
Monitor and evaluate the safety of responsible products, including butnot limited to evaluating individual case safety reports, signaldetection, signal evaluation, recommendation for action andcommunication of safety information. 监测和评价所负责产品的安全性，包括但不限于对个例安全报告的医学评估，安全信号监测、评价、行动建议和沟通。
3.Evaluate and communicate product safety risks. Provide risk managementsuggestions accordingly. Lead and oversee the implementation of riskmanagement activities. 评价和沟通产品安全风险。根据情况提供风险管理意见。领导监督风险管理活动的实施。
4.Write and review safety parts of clinical documents, including but notlimited to Development Safety Update Report, Periodic Safety UpdateReport （PSUR）, Investigator’s Brochure, Company Core Safety Information,labels, protocols, Clinical Study Reports, Informed Consent Forms, riskmanagement plans. 参与药物临床文件安全性部分的撰写和审阅，包括但不限于药物开发期安全性更新报告、定期安全性更新报告、研究者手册、公司核心安全信息、说明书、研究方案、临床研究报告、知情同意书、风险管理计划等。5.
Perform literature case search and process. 文献病例检索和处理。
6.Cooperate with relevant functions to address safety related issues. 和相关部门合作处理安全问题。7.
Communicate with health authority for safety relevant problems. 就安全性相关问题与药监部门进行沟通。8.
Be responsible for response to safety inquiries. 负责安全性问询的回复。
9.Provide safety relevant trainings to internal and external staff. 对内部员工和外部人员提供药品安全相关培训。10.
Be familiar with and ensure adherence to pharmacovigilance relevantregulations and company standard operational procedures (SOP). 熟悉并遵守药物警戒相关法规和公司标准操作流程(SOP)。11.
Develop, update or review drug safety relevant SOPs. 参与药品安全相关SOP的撰写、更新或审阅。12.
Ensure PV inspection and audit readiness. Support inspectors andauditors. 确保监查和稽查准备就绪。支持监查和稽查。13.
Perform other safety work assigned by supervisor. 执行领导分配的其他安全性工作。




任职要求：
1.Major in clinical medicine, bachelor degree or above. 临床医学，本科及以上学历。
English level is equal to or above CET-4. 英语水平CET-4或以上。
2.Good computer skill; familiar with internet and office software.熟练使用计算机、网络和办公软件。3.
Good adaptive capacity. Ability to work under time limitation andpressure. Excellent problem analysis and solving skills.具有良好的适应能力。能在时间限制和压力下工作。具有优秀的问题分析和解决能力。4.
Strong sense of responsibility. Good team work and communication skills.具有高度责任心。良好的团队合作能力和沟通能力。