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Primary Responsibilities:
1. Responsible for ensuring global regulatory reporting compliance by execution of processes and compliance with procedures for processing safety reports originating from clinical studies, literature, hotline, regulatory feedback data, social media and/or other sources for post-marketing 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 safety database in accordance with ClinChoice and/or client conventions/guidelines and SOPs and liaising with the client if applicable.
3. Performing quality review for the data entry in the safety database.
4. Ensuring the timely completion and distribution of AE/SAE/SUSAR/ADR/SADR reports to Health Authorities, client and/or client’s business partners etc..
5. Ensuring 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.
8. Interacting with internal or external contacts to resolve issues related to the cases.
9. Responsible for documents archiving in the filing system.
10. Supporting PV project managers to perform project management related work, including but not limited to: SAE reconciliation, revenue recognition, ERP system maintenance, client communication, project document preparation, etc..
11. Mentoring or training junior staff or new joiners as needed.
12. Responsible for safety database creation and maintenance if applicable.
13. Other ad-hoc tasks assigned by PV leadership team.
Qualifications
1. Degree in life sciences or a prior experience in PV would be desirable (1-3 years of PV in experience.).
2. The minimum qualification required would be a college/bachelor’s 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 of SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, Clinical trial guidelines).
6. Experience in processing safety data within Argus preferred.