Drug Safety Associate/Drug Safety Officer

  • 更新时间:2016-02-29
  • 学历:硕士
  • 工作地点:北京市
  • 语言要求:英语
  • 工作年限:1年以下
  • 招聘人数:1
  • 月薪:0-0元
  • 性质:

Job Focus
Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer’s products and to meet regulatory requirements. Determination of local submission of individual and, where appropriate, aggregate safety reports.

- Carry out case processing activities

- Review, rank, verify process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments

- Review case criteria to determine the appropriate workflow for case processing

- Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately

- Write and edit the case narrative

- Determine and perform appropriate case follow-up, including generation of follow-up requests

- Review processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenarios

- Liaise with key partners, locally , and other stakeholders regarding safety data collection and data reconciliation

- Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database

- Determine reportability of scheduled reports , ensuring adherence to regulatory requirements

- Consistently apply regulatory requirements and Pfizer policies

- Participate, as appropriate, in local, internal and external safety activities

- Supporting Inspection Readiness as needed

1. Educational /Training

- Educational: Bachelor or above, Medical background is preferred

2. Working Experiences

- Experience in clinical practice/pharmacovigiliance field in industry is preferred

- Experience in any aspects of drug information

- Experience in any therapeutic areas



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