职位描述:

1. 进行个例安全报告管理，以高效完成下述活动，达成工作目标:

a) 负责临床PV部门公共邮箱的管理。

b) 保障所有临床试验中PV部门收到的个例安全报告（首次、随访或质疑回复）严重不良事件的分拣、内部质控和归档有序进行。

c) 根据适用的监管部门法规和诺诚健华的SOP，负责管理向诺诚健华产品和临床试验所涉及的监管部门（包括中美欧澳等）快速递交与试验药物相关的安全性信息。

d) 改善PV系统的个例报告管理，以确保其更有效，并保证PV个例报告管理活动处理流程符合SOP和适用的法规。

e) 承担PV数据库超级用户的责任。

f) 负责与个例报告管理相关的质量及合规控制过程，以确保质量和合规性，包括个例报告延迟递交的根本原因分析，建立和管理纠正措施和预防措施。进行抽样质控，生成质量指标数据，完成质量分析。

g) 监督与个例报告管理处理相关的CRO管理活动，审查CRO质量指标数据。

2. 支持PV团队其他与个例安全性报告相关的工作

a) 支持美国NDA和BD，负责协调个例安全报告的翻译。

b) 支持NDA项目中SAE详述文件的准备，按需整理和提供个例安全报告原始报告。

c) 支持定期安全性更新报告的安全数据库来源的数据准备和审阅。

d) 支持产品信号监测过程中安全数据库个例安全性报告数据准备。

e) 起草撰写SAE周报、月报以及SUSAR月报。

f) 生成提供SAE 行列表，用于支持SAE一致性核查和其他事项。

3. 参与CRO审计。

4. 完成主管交办的其他工作。

Key Objectives/Deliverables:

1. Responsible for ICSR management aiming at achieving high efficiency and productivity on following activities：

a) Responsible for the management of public mailbox of Clinical PV.

b) Ensure all activities of case management including triage, internal QC and archiving of all clinical ICSR (initial, follow up or query response) received by PV were carried out in an orderly manner.

c) Manage the expedited submission of safety information related to investigational drugs to Regulatory Authorities that InnoCare products and clinical trials involved (including the Authorities in China, the US, EMA, Australia, etc.), in compliance with applicable health authority regulations and InnoCare's SOPs.

d) Participate in improving the case management process in PV database to ensure its efficiency and the process in compliance with SOP and applicable regulations.

e) Take the role of PV database super-user.

f) Responsible for the Quality Control (QC) and compliance control process related to case management to ensure Quality and Compliance, including root cause analysis of late submission, establishing, and managing CAPAs. Conduct Sampling QC, generate quality metrics and complete quality analysis.

g) Supervise the CRO management activities related to case processing, and review CRO quality metrics.

2. Provide supports to PV team for other ICSR related tasks

a) Coordinate ICSR translation to support US NDA and BD.

b) Prepare SAE narrative and collect ICSR source documents to support NDA.

c) Prepare and review data from safety database to support DSUR generation.

d) Prepare data from safety database to support the signal detection.

e) Develop SAE weekly/monthly report and SUSAR monthly report.

f) Generate SAE line listing to support SAE reconciliation and others.

3. Participate in CRO audit.

4. Other tasks as assigned.

任职条件:

1. 医学、药学、公共卫生、流行病学等相关专业，本科以上学历；

2. 4年及以上药物警戒工作经验并有PV数据库操作经验者优先；

3. 英文读写精通，熟练操作办公软件；

4. 工作积极高效、有责任心和团队精神、并有较强的学习能力。

Qualifications:

1. Medical, pharmacology, public health, or epidemiology background, etc. And a bachelor's degree or above.

2. At least 4 years of PV working experience and PV database operating experience is preferred.

3. Excellent in English reading and writing, proficient in office software.

4. Work actively and efficiently, have a strong sense of responsibility and team spirit, and have a strong learning ability.