Clinical Trial Hub Safety Associate

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  • 单位性质:外商独资/代表处
  • 单位行业:科学研究和技术服务业
  • 单位规模:500-1000人
  • 月薪:6000-7999
  • 招聘人数:10人
  • 发布日期:2018-05-23
  • 职位性质:全职
  • 职位类别:医疗/卫生/制药/生物类
  • 工作地点:湖北省 - 武汉市
  • 学历要求:本科
  • 工作经验:不限
  • 语言能力:英语
  • 简历申请邮箱
信息来源:湖北大学就业创业信息网 温馨提示:求职需提高谨慎,辨别信息真伪,勿上当受骗。


  • ·Review, preparation, and completion of clinical study and compassionate use sourced adverse event (AE)/serious adverse event (SAE) reports, 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 book-in, data entry and processing activities.

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

  • Identify and select cases for data entry, determining appropriate prioritization criteria, and noting reasons for any delays.

  • Review, rank, process and document case-related information: event terms; case classifications (validity, seriousness, expectedness/listedness/labeledness), special scenarios, product complaint information, reportability with due date; and accuracy and consistency.  Based on case assessment, forward the case to the appropriate workflow.

  • Write and edit the case narrative.

  • Consistently apply regulatory requirements and Pfizer policies to determine reportability of scheduled reports, generate reports, and ensure adherence to regulatory compliance timelines.

  • Determine and perform appropriate case follow-up, including generation of follow-up request letters when appropriate.

  • Liaise with key partners, including Global Pharmacovigilance Organization, Pfizer Safety Surveillance and Reporting Centers of Excellence, Clinical Development, License Partners, and other stakeholders regarding clinical study and compassionate use sourced AE/SAE collection, data reconciliation, and AE/SAE distribution/submission.  Participate, as appropriate, internal and external safety activities.

  • Develop and maintain expertise and knowledge of all products within the Pfizer portfolio, applicable corporate and global regulations, guidelines, Standard Operating Procedures and written practices, data entry conventions, and search functions in the safety database.



  • Bachelor’s degree in a science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification preferred.

  • Ability, with supervision, to solve routine problems and to surface issues constructively.

  • Ability to make basic decisions with an understanding of the consequences. 

  • Ability to achieve personal objectives while meeting departmental standards of performance

  • Ability to work under supervision in a matrix organization