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安全医生（南京）(J16731)

CTTQ Pharma · 江苏省·南京市

Imported listingfull-timeabout 1 month ago

About The Role

  1. 负责个例报告的相关性评价和医学评估；
  2. 负责审阅临床试验方案中的安全性信息，参与方案的修订；
  3. 负责进行风险管理，并制定、执行和评估风险管理计划；
  4. 负责识别、确认和评估风险信号；并选择、执行和评估风险最小化措施；
  5. 负责撰写、审核和提交定期安全性更新报告和研究期间安全性更新报告；
  6. 负责回答在临床试验申请递交时来自监管部门的安全性相关问题；
  7. 参与药政事务、临床运营、数据管理和统计分析各职能部门的合作。
  1. 硕士及以上学历，英语六级，临床医学相关专业；
  2. 良好的沟通与协调能力，富有团队精神。

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