1. 隶属部门/Situation in structure
属高级医学经理直接领导
Directly lead by Senior Medical Manager

2. 职责/Mission
负责PV相关工作
Responsible for PV related work

3. 主要工作/Main Activities
61 确保对其负责的产品安全文件进行适当的监督
61 协助建立药物警戒系统并且维护此系统
61 确保本企业中的药物警戒活动符合国家法律法规及相关要求
61 协助配合食品药品监督管理部门、卫生主管部门和药品不良反应监测机构对药物警戒相关工作的视察
61 负责保持本地药物警戒SOP文件与总部的EUQPPV的紧密联系
61 协助配合公司总部、合作伙伴等对药物警戒相关工作的审计
61 收集公司产品相关的药物警戒信息。对药品不良反应/事件报告进行调查、分析和处理；填写“药品不良反应/事件报告表”；按规定报告；采取有效措施，减少和预防药品不良反应的反复发生查
61 追踪公司药品不良反应报告，利用收集到的信息对药品不良反应进行分析和研究，并根据规定对药品的生产流程、包装、传单和报告等方面提出修改意见，以提高药品的安全性和有效性
61 发现人群不良反应事件时，立即向药品监督管理部门、卫生行政部门和药品不良反应监测中心报告
61 协助配合食品药品监督管理部门、卫生主管部门和药品不良反应监测机构对药物警戒相关工作的视察
61 支持其它部门相关工作

61 Ensure appropriate oversight of safety profiles for products under her/his responsibility.
61 Assist the establishment of pharmacovigilance system and also maintain the pharmacovigilance system.
61 Ensure the PV activities inside the company are compliant to the national law, regulation and relevant requirements.
61 Assist the coordination of PV inspection from the drug administration departments, the health administrative department and ADR monitoring center.
61 Maintain local PV SOPs and close relationships with the EUQPPV at the headquarter.
61 Assist the coordination of PV audit from the headquarter, partner or others.
61 Collect the pharmacovigilance information of SEP products, find out any ADR record relevant to drugs manufactured by SEP. Investigate, analyze and handle the records; fill in the ; report according to regulation; take effective measure to reduce and prevent repeated ADR cases of drugs
61 Follow up the ADR report of drugs manufacturing by the company; analyze and study the ADR with the collected information; propose the revision on the manufacturing process, packing, leaflet, and report according to the regulation, to improve the drug safety and efficacy.
61 When discover the Group Adverse Drug Reaction Events, report to the Drug Administration department, the health administrative department and ADR monitoring center of local province, autonomous region or municipal city immediately.
61 Coordinate the PV inspection from the drug administration depart, the health administrative depart and ADR monitoring center
61 Supporting other departments.
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4. 能力要求/Competence
61 本科及以上学历，临床或药学专业，3年以上PV经验
61 熟悉有关药物警戒相关法规和工作程序
61 认真负责、耐心细致
61 熟练的办公软件操作技能，尤其是PPT和Excel
61 良好的英文能力
61 优秀的沟通及人际交往能力
61 良好的问题解决能力
61 团队合作精神

61 Bachelor or advanced degree in clinical or pharmacy qualification, with 3 year on relevant experience of PV in pharmaceutical company.
61 Familiar with relevant regulations and working procedures.
61 Responsible, patient and cautious.
61 Advanced skill level with Microsoft Office, esp. PPT and Excel.
61 Good command of English.
61 Strong communication and interpersonal skills.
61 Good problem-solving skills.
61 Teamwork Spirit.