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Pharmacovigilance doctor
Work location
Room A708, Building 1, No.600 Huaxi Road, Minhang District, Shanghai
Job type
Technical position
Job responsibilities
1, responsible for participating in the company's pharmacovigilance system process documents writing and updating;
2. Responsible for writing or reviewing the safety parts of pharmacovigilance master file, PSUR, annual review report, DSUR, safety management plan, RMP, RCP, etc.;
3. Review the protocol of clinical trial phase, informed consent, investigator manual, CRF, etc.;
4. Use and review risk identification tools such as safety signal detection and batch number clustering trend, analyze and evaluate identified risks, and form analysis and evaluation records;
5. Responsible for the medical review of individual case reports of drug safety during clinical trials and after marketing.
6. Take the initiative to provide medical support in pharmacovigilance and other functions.
7. Complete other work arranged by superiors.
Qualification
1. Major in clinical medicine, master degree or above;
2, at least 2 years of hospital clinical practice experience, clinical trial related work experience is preferred, preferably in the field of ophthalmic treatment;
3, familiar with at least one treatment field clinical application knowledge, GCP, clinical trial standard operating procedures.