国产一区二区免费,翔田千里AV,无码电影,红杏亚洲影院一区二区三区,国产精品欧美激情

崗位職責(zé)： 1、Responsible for medical evaluation of clinical trials and post-marketing drug ICSRs； 2、Responsible for writing or reviewing drug safety parts of documents such as IB, clinical trial protocol, ICF, clinical study report /summary, clinical study safety data review and summary； 3、Responsible for drug safety signal detection, evaluation and management, including drug benefit-risk evaluation； 4、Responsible for Chairing the product safety management committee for safety identification, assessing if IB/RMP update required and if any actions to be taken； 5、Responsible for writing the Risk Management Plan and review relevant documents for IND and NDA submission； 6、Provide pharmacovigilance training and coaching for new employees； 7、Responsible for the pharmacovigilance annual summary report； 8、Responsible for writing PSUR/DSUR, etc. ； 9、Responsible for the communication of drug safety information, such as initiating company drug safety committee meetings； 10、Writing relevant PV system documents, such as SOP and WI； 11、Support the convening of the safety audit committee； Complete other works and tasks assigned by the PV head and company upper managers in time. 任職要求： 1、Bachelor degree or above in medicine related majors. 2、8 years or above medical work experience in medical industries; 8 years or above PV related work experience; 5 years or above PV Physician experience. 3、Familiar with industry laws and regulations, and the ability to interpret in-depth regulations; 4、Good English oral communication skills; 5、Have certain experience GVP and or GCP audits; 6、Familiar with the operation of pharmacovigilance database systems (eg Argus, Arisg). 7、 Excellent communication, coordination, execution and management skills.