Clinical Trial Hub Safety Associate

辉瑞(武汉)研究开发有限公司
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  • 单位性质:外商独资/代表处
  • 单位行业:其他
  • 单位规模:500-1000人
  • 月薪:6000-7999
  • 招聘人数:10人
  • 发布日期:2018-06-08
  • 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:chinajob-wrdc@pfizer.com
信息来源:湖北科技学院就业信息网 温馨提示:求职需提高谨慎,辨别信息真伪,勿上当受骗。
岗位说明:

职位概述:

  • ·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.

 

工作职责:

  • 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.

 

任职资格:

  • 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

    在辉瑞,我们致力于运用科学以及我们的全球资源来改善每个生命阶段的健康状况。在药品的探索、开发和生产过程中,我们致力于设定品质、安全和价值标准。我们多样化的全球保健产品包括生物药品、小分子药品和疫苗,以及许多世界驰名的健康药物。每天,世界各地的辉瑞员工致力于推进健康,以及能够应对我们这个时代最为棘手的疾病的预防和治疗方案。辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作,支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来,辉瑞一直努力为人们提供更好、更优质的服务。

    我们的目标是“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为卓越的创新型生物制药公司”。


    辉瑞(中国)研发有限公司与武汉国家生物产业基地(光谷生物城)2010年10月8日签订合作协议,宣布辉瑞武汉研发中心正式成立。武汉市委副书记、市长阮成发指出:“辉瑞武汉研发中心的成立不仅有助于加速武汉和湖北生物制药产业的发展,还将推动整个华中地区生物制药领域的发展。数家全球知名制药企业表达了与光谷合作意向,光谷生物产业,向全球知名、全国领先目标更进一步。辉瑞武汉研发中心是辉瑞目前在辉瑞上海研发中心的扩展,成为开展全球生物和药物开发与研究技术战略合作平台。湖北省市领导罗清泉李鸿忠杨松、阮成发齐聚光谷生物城。辉瑞全球董事长兼首席执行官杰夫.金德勒也率该公司多位重量级人物前来,共贺辉瑞武汉研发中心成立。