当前位置:首页>职位列表>职位详情
Pharmacovigilance Physician Director(药物警戒医生) 面议
南京建邺区 应届毕业生 不限
南京维立志博生物科技有限公司 2025-06-08 03:21:11 25人关注
职位描述
岗位职责: 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. 任职要求: 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.
联系方式
注:联系我时,请说是在今日招聘网上看到的。
工作地点
地址:南京建邺区建邺区南京维立志博生物科技股份有限公司
以担保或任何理由索取财物,扣押证照,均涉嫌违法,请提高警惕

若您已有简历,可直接登录登录

  • 省份

    注:0表示面议
    获取验证码
    保存并投递
    投递简历
      马上投递
      投递简历
        马上投递

        企业
        服务热线

        • 400-6680-889
        1. 登录
        2. 注册
        客户服务热线:
        400-6680-889
        在线客服:
        点击这里给我发消息 898995850
        工作日:
        8:30-18:00