Scope of responsibilities:
1. Medical review of individual case reports, including medical review opinions of adverse events for marketed products and assessment of SAEs for anticipation and causality during clinical trials;
2. On the basis of drug safety information, identify, confirm and evaluate risk signals, and detect new risks or changes in known risks of the drugs for which they are responsible as early as possible;
3. Reviews of clinical trial materials，such as research protocols, researcher manuals, ICF, e-CRF, consistency comparison plans, CSR, etc;
4. Responsible for preparing reviews of periodic reports including DSUR;
5. Collaboration with preclinical and clinical departments to develop risk control plans during clinical trials;
6. Generation and updating of drug risk management plans;
7. Regular reviews for the literature to keep abreast of the latest product knowledge, especially safety information, and to provide a basis for relevant decisions;
8. To combine internal and external medical experts as necessary to add to medical opinions;
9. To coordinate and organize drug safety committee meetings;
10. Responsible for the preparation of pharmacovigilance-related documentation required for IND/NDA registration.
1. Master's degree or higher in a medical related field;
2. 3+ years of work experience in PV or as a clinician, preferably in oncology or as a physician;
3. Familiarity with NMPA, ICH and relevant regulatory guidelines of major international regulatory agencies such as FDA/EMA;
4. Able to efficiently write and review high-quality and complex documents such as the drugs for clinical research protocols, CSR safety sections/DSUR/RMP;
5. Experience in using drug safety databases.