工作职责:
岗位目的：
As the leader of a pharmacovigilance operation team, lead several independent contributors to complete clinical trials and/or post-marketing safety assessment and related report writing.
作为药物警戒运营某小组负责人，带领多个独立贡献者共同完成临床试验和/或上市后安全评估与相关报告撰写工作。
岗位职责：
Responsible for leading a pharmacovigilance operation team to complete pre-marketing and/or post-marketing pharmacovigilance operation activities as required. Ensure that all PV activities conform to the requirements of laws and regulations of regulatory authorities and relevant SOPs of the company and are carried out in a timely and effective manner throughout the drug life cycle. Cooperate with department to set up and improve pharmacovigilance system according to laws and regulations, guidelines and company SOP requirements.
带领药物警戒运营某小组按照要求完成上市前和/或上市后的药物警戒运营相关活动。在整个产品生命周期中，确保各项药物警戒活动符合监管机构法律法规和公司相关SOP的要求及时有效进行。依照法律法规、指南及公司SOP要求，配合部门建立、完善药物警戒体系。
1. Quality Management
质量管理
1） Supervise the quality of individual safety reports of the team in charge, and control the accuracy of individual safety report data when necessary.
监管所负责小组的个例安全报告质量，需要时，对个例安全报告数据的准确性进行质量控制。
2） Review or sign the documents related to pharmacovigilance.
对药物警戒相关文档提供审核或签批。
3） Supervise the related projects of the team in charge can be implemented according to the requirements
监管所负责小组的相关项目能够按照要求执行。
4） Review the investigation of death cases and group safety event.
复核死亡病例和群体安全性事件调查。
2. Compliance Management
合规管理
1） Be familiar with the submission requirements and timeline of individual safety reports, periodic reports and other submission reports, and supervise the compliance of the team in charge.
熟悉个例安全报告、周期性报告和其他递交报告的递交要求和时限，监管所负责小组的合规情况。
2） Familiar with laws, regulations and guidelines related to pharmacovigilance.
熟悉药物警戒相关法律法规及指南。
3） Write and update the company's pharmacovigilance related SOPs.
撰写、更新公司药物警戒相关SOP。
4） Participate in or support internal, external and regulatory audits and inspections.
参与或支持公司内部、外部及监管机构稽查、检查。
3. Project Management
项目管理
1） Provide support for the smooth implementation and operation of the related projects of the responsible team.
为所负责小组的相关项目顺利开展和运行提供支持。
2） Maintain and manage vendors and license partners, and write or review relevant documents.
对供应商、协议伙伴进行维护与管理，撰写或审阅相关文件。
4. Establishment and supervision of pharmacovigilance system
药物警戒体系搭建和监管
1） Assist the superior to build and improve the pharmacovigilance system.
协助上级搭建和完善药物警戒体系。
2） Assist in monitoring the operation of pharmacovigilance system.
协助监管药物警戒体系的运行情况。
5. Personnel Management
人员管理
1） Perform performance management and administrative management on team members.
对小组成员进行绩效管理和行政管理。
2） Ensure team members have completed the necessary training for the post.
确保小组成员完成岗位必需培训。
任职资格:
任职资格：
1. Bachelor degree or above, major in medicine, pharmacy, biology, etc.
本科及以上学历，医学、药学、生物学等相关专业
2. Familiar with domestic and foreign laws, regulations and guidelines related to pharmacovigilance.
熟悉国内外药物警戒相关法律法规及指南
3. At least 5 years experiences in pharmacovigilance
5年以上药物警戒相关经验
4. Excellent English listening, speaking, reading and writing skills are preferred.
英文听说读写能力优秀者优先。
5. Experience with drug safety database, such as Argus, is preferred.
有药物安全数据库使用经验，如Argus优先。
6. Good communication skills, time management skills, analysis skills, team work skills, and strong problem solving skills.
有较强的沟通能力、时间管理能力，分析能力，团队协作能力，同时有较强的问题解决能力。