Drug Safety and Medical Information Officer
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职位描述/要求:
Responsibilities:
- Collect and handle each medical complaint ensure that all AE/SAE be reported in accordance with GDS, Company SOP and Chinese regulation.
- Submit overseas SAE case repot of imported products to local authority according to local Drug Safety regulation.
- Submit overseas SAE case repot of imported products to local authority according to local DS regulation.
- Answer and handle ADR hotline according to Hotline answering and handling SOP.
- Keep positive relationship with relative department of SFDA and BJADRMC.
- Check and approve all promotion materials (including package insert) from medical requirement, responsible for evaluating the material for medical and scientific accuracy as timeline in SOP.
- Handle emergency crisis related safety; collect relevant information, archive and summary.
- Be responsible for handling some requirement that published at global website from China .
Requirements :
- Bachelor degree or above, major in clinical medicine;
- More than four years medical/pharmaceutical working experience include at least two years experience of clinical doctor. More than one year CRA experience is preferred;
- Eager to face challenges, and good self-learning ability;
- Good English ability both in written and oral;
- Good knowledge in Microsoft, Word, Excel, PowerPoint, etc
联系方式:

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