岗位职责：

1.管理收集/处理/记录/报告来自临床试验、非干预性研究、文献、自发报告等的产品相关的个例安全性报告，确保向总部和监管部门递交的报告时限和质量。

Manage collection/ processing/documentation/ reporting of all individual case safety reports from clinical trials, non-interventional studies, literature, Spontaneous Reports, etc., to ensure the timeline and quality of the reports submitted to the headquarters and regulatory authorities.

2.负责领导和协调公司内部与临床和上市后研究相关的药物警戒（PV）活动，监督和指导整个研究过程中的PV活动实施，包括制定PV相关的工作流程、与内部和外部利益相关者沟通、与总部PV团队联络以及指导初级员工。

Responsible for leading and coordinating pharmacovigilance (PV) activities related to clinical and post-marketing studies within the company, overseeing and directing PV activities throughout the studies process, including defining PV-related workflows, communicating with internal and external stakeholders, liaising with headquarters PV teams, and mentoring junior staff members.

3.监督药物安全服务供应商，确保供应商提供的服务符合公司需要，预期和合同的义务。

Oversee drug safety service vendors to ensure vendor’s output is consistent with company needs, expectations, and contractual obligations.

4.与第三方供应商沟通和交换相关安全性信息（如适用）。

Interact and exchange relevant safety information with third parties, if applicable.

5.制定、更新和实施本地ICSR相关流程，确保符合总部标准操作流程和国家法规的要求。

Develop, update and implement local ICSR related procedures to ensure compliance with global standard operation procedures and national regulatory requirements.

6.与其他部门就医学问题、质量投诉和其他来源的潜在不良事件进行核对。

Perform reconciliation with other departments for potential AEs resulting from medical inquiries, quality related complaints and other sources.

7.管理和维护药物警戒系统。

Management and maintenance of pharmacovigilance databases.

8.及时完成ICSR合规性报告。

Prepare reports on ICSR compliance in a timely manner.

9.支持完成汇总报告的相关活动。

Support on aggregate safety reports related activities.

10.与合作伙伴就合作、项目执行和流程相关问题建立并保持有效的关系。

Establishes and maintains effective relationships with partners regarding collaboration, project execution, and process-related issues.

11.支持药物警戒流程的一致性和质量保证活动。

Supports consistency and quality assurance activities for pharmacovigilance process.

12.参与药物警戒活动的稽查/检查的准备。

Contributes to audit/inspection readiness for pharmacovigilance activities.

13.参与相关药物警戒岗位候选人的甄选和遴选工作。

Involve in identification and selection of candidates for the relevant pharmacovigilance positions.

14.根据需要向公司内部提供指导和培训。

Provide mentoring and training within the company as needed.

资历要求：

1、医学、药学、流行病学或相关背景，具有学士/硕士学位。

Medical, pharmaceutical, epidemiology or related background with bachelor/master degree.

2、5年以上药物警戒/药物安全相关制药行业经验。

At least 5 years relevant pharmaceutical industry experience in pharmacovigilance/drug safety.

3、英语书面和口语表达俱佳。

Fluent in both written and spoken English language.

4、了解国家和国际药物警戒法规的最新知识，具有经证实的安全运营项目管理经验，具有优秀的CRO/供应商管理技能或CRO工作经验者优先。

Advanced knowledge of national and international regulations for pharmacovigilance. Demonstrated experience in safety operation project management. Excellent CRO/vendors management skills or CRO working experience is preferred.

5、良好的人际交往能力和多任务管理能力。

Good interpersonal skills and multitasks management ability.

6、熟练使用常用办公软件，熟悉RPA、AI等工具。

Proficient in the use of Microsoft offices, familiar with RPA, AI and other tools