Pharmacovigilance Manager or Senior Manager 部门:Clinical Development  工作类型:Full time, Employee
工作地点:Shanghai, China
立即申请
职位申请

Responsibilities:


  • Lead pharmacovigilance activities for assigned clinical trials
  • Review all adverse events received from CROs for ongoing clinical trials and process them in internal database.
  • Working with CRO to ensure reporting compliance with regulatory agency reporting requirements worldwide.
  • Training and certification activities for PV department.
  • Serve as local expert by ensuring the appropriate SOPs and guidelines are available and routinely updated. Stay abreast of regulatory updates.
  • Develop and support different strategies to improve team performance.
  • Continually monitor for opportunities for process improvement to improve efficiency and effectiveness and implement changes as appropriate.
  • Provide technical level process expertise and conduct periodic assessments to ensure established processes are being followed in a consistent and appropriate manner.


Qualification:


  • BS, MS, or MD in medicine, nursing or biology
  • Industry experience of which 3-5 years is relevant to pharmacovigilance/drug safety knowledge
  • Good verbal, written and presentation skills in English and Chinese
  • Good communication skills
  • Knowledge of medical and drug terminology
  • Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
  • Knowledge of worldwide regulatory requirements and reporting of adverse event for investigational products
  • Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance
  • Title and compensation commensurate with qualifications and experience
  • Proactive and organized with exceptional follow-up
  • Anticipate/ identify problems and takes appropriate action to correct
  • High degree of accuracy with attention to details