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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.


Qualification：

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).

6. Experience in processing

safety data within Argus preferred.