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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, SOPs and liaising with the client if applicable.
3. Responsible for medical coding with MedDRA, WHODrug or other dictionaries, and narrative writing and safety review if applicable.
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. Supporting safety database creation and maintenance if applicable.
9. Supporting documents archiving in the filing system.
10. Other ad-hoc tasks assigned by PV leadership team.