作为临床研究中药物警戒运营相关活动的内/外部利益相关者的联络人，管理和协调相关事务，建立/优化流程，监督管理整个流程以确保相关活动高质量地执行

Serve as a liaison for internal/external stakeholders in activities related to pharmacovigilance operations in clinical studies, manage and coordinate related affairs, establish/optimize processes, and oversee the entire process to ensure the high-quality execution of related activities.

岗位职责：

1.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 timely and accurate execution of PV tasks.

a)制定研究中统一实行的PV标准化工作流程和模板（如SMP，AE package），并保持与总部PV策略一致。

Develop and implement standardized processes and templates for PV studies (e.g. SMP, AE package) and ensure consistency with headquarters' PV strategy.

b)作为PV窗口人负责与内部和外部利益相关者有效沟通，包括临床运营团队、供应商、总部PV团队和监管机构，以解决PV相关问题并确保项目顺利执行。

Play as PV window person to communicate effectively with internal and external stakeholders, including clinical operation teams, vendors, headquarters PV teams, and regulatory authorities, to address PV-related issues and ensure smooth project execution.

c)领导研究中SMP的制定和实施，协调和参与PV相关文件（如SAE reconciliation plan）的审阅，监督EDC中AE alert notification和AE package customer report等功能配置。

Lead the development and implementation of SMP in studies, coordinate and participate in the review of PV-related documents (such as SAE reconciliation plan), and oversee the configuration of functions such as AE alert notification and AE package customer report in the EDC.

d)监督供应商和内部团队执行研究中PV相关活动，主动识别并解决问题，以确保PV活动按照项目指南和时间表进行。

Supervise the execution of PV activities by vendors or the internal team, proactively identify and address issues to ensure that PV activities are conducted in accordance with the project guidance and timeline.

2.为上市后药物警戒运营提供支持，包括：个例报告处理、质控，文献检索、AE报告核对等

Support post-marketed PV Operations, including ICSR processing and QC, literature search, AE reconciliation, etc.

3.参与制定、更新和实施程序文件，以确保符合全球标准操作程序和国家监管要求。

Participate in developing, updating, and implementing procedure documents to ensure compliance with global standard operating procedures and national regulatory requirements.

4.支持药物警戒系统维护。

Support the maintenance of pharmacovigilance databases.

5.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.

6.参与药物警戒活动的稽查/检查的准备。

Contributes to audit/inspection readiness for pharmacovigilance activities.

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’s degree

2.3-5年药物警戒/药物安全相关制药行业经验，同时有上市后药物警戒操作经验者优先

3-5 years relevant pharmaceutical industry experience in pharmacovigilance and clinical study, with experience in post-marketing pharmacovigilance operations is a plus

3.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

4.熟练的英语书写和口语

Proficiency in English, both written and spoken