主要职责：

按照监管要求和标准操作规程向总部和监管部门报告，确保个例安全性报告的报告时限和质量要求。

Report to the headquarters and regulatory authorities in accordance with regulatory requirements and standard operating procedures, to ensure the reporting timeline and quality requirements of individual case safety reports.

具体职责：

1. 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、合作伙伴和监管部门递交的报告时限和质量。

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, license partners and regulatory authorities.

2. 领导和协调与临床研究中有关的PV运营活动，确保及时准确地执行PV任务。

Lead and coordinate PV operation in clinical studies, ensuring the timely and accurate execution of PV tasks.

3. 协助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。

Support in overseeing safety service vendors to ensure vendors’ output is consistent with the company's needs, expectations, and contractual obligations.

4. 参与制定，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。

Participate in developing, updating, and implementing local ICSR-related procedures to ensure compliance with global standard operating procedures and national regulatory requirements.

5. 与其他部门就医学问询、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.

6. 维护药物警戒系统。

Maintenance of pharmacovigilance databases.

7. 支持完成ICSR合规性报告。

Support the completion of ICSR compliance reports.

8. 支持完成汇总报告的相关活动。

Support the completion of aggregate report-related activities.

9. 参与药物警戒活动的稽查/检查的准备。

Contributes to audit/inspection readiness for pharmacovigilance activities.

10. 根据需要为内部和外部人员提供培训。

Provide training to internal and external personnel as needed.

11. 向初级员工提供辅导和支持

Mentor and support junior staff

任职资历：

 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 a bachelor's/master’s degree

 5-7年药物警戒从业经验，同时有PV数据库管理经验者优先

5 to 7 years of experience in pharmacovigilance, with expertise in safety database management being a plus

 熟悉与临床研究相关的PV法规和指南，如ICH、FDA、NMPA等

Familiar with PV regulations and guidelines related to clinical research, such as ICH, FDA, NMPA, etc.

 较强的沟通能力，能够与各级内部和外部利益相关者进行有效沟通。

Strong communication skills, able to effectively communicate with internal and external stakeholders at all levels.

 注重细节，具有较强的组织能力，能够同时确定和管理多项任务。

Detail-oriented with strong organizational skills, able to prioritize and manage multiple tasks simultaneously.

 主流安全数据库（Argus、Arisg等）和EDC系统的经验。

Experience in mainstream safety databases (Argus, Arisg, etc.) and EDC 系统

 熟练的英语书写和口语

Proficiency in English, both written and spoken

 熟练使用各类常用办公软件，有人工智能、自动化工具开发运用经验者优先

Proficient in the use of various common office software, experience in the development and/or utilization of artificial intelligence and automation tools being a plus