Primary

Responsibilities:

1.    Is responsible for ensuring global regulatory reporting compliance by execution of processes and compliance with procedures for processing adverse experience reports originating from

clinical studies, literature, and the marketplace for client specific products.

2.    Identifying and capturing accurately the relevant information of ICSRs (Including serious and non-serious cases from unsolicited and solicited origin; and literature cases, as required) in the client’s database in accordance with client conventions/guidelines and SOPs, and liaising with the client if applicable.

3.    Is responsible for narrative writing.

4.    Ensures the timely completion and distribution of AE/SAE reports to Health Authorities, client partners, and clients.

5.    Ensures timely identification of Individual Case Safety Reports and/or relevant safety information during the monitoring of the literature.

6.    Maintaining a basic working knowledge of the adverse event safety profile of assigned drugs and labeling documents or IB.

7.    Requesting additional information from the appropriate sender (investigators, medical representatives etc.), as required.

Qualifications

1.    Degree in life sciences’ or a prior experience in PV would be desirable.

2.    The minimum qualification required would be a college/bachelor degree.

3.    Basic conversational skills in English required.

4.    Computer proficiency, an ability to work with web-based applications, and familiarity with the Windows Professional Operating System and the MS office suite (MS Word/Excel/PowerPoint).

5. Demonstrate understanding or ability to learn and demonstrate understanding of SOPs, WPDs, and relevant regulations e.g. ICH/GCP, Clinical trial guidelines).

其他信息
语言要求：英语、普通话