产品安全监督与报告专员 武汉

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该公司所有职位
  • 无工作经验
  • 本科
  • 招若干人
  • 11-09 发布

职位描述

职位描述： Organizational Relationship(s) including to whom the position reports (JD Job Title):Reports to Therapeutic Area Team Lead向治疗领域小组负责人汇报Position PurposeReview, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer’s products and to meet regulatory requirements.审核，准备，完成药物不良经历报告，帮助认识辉瑞产品的安全面貌，并符合法规报告要求。Primary Responsibilities · Provide professional evaluation to Individual Case Safety Report (ICSR) in Pfizer Safety Database, including but not limited the activities as follows.在辉瑞安全数据库中，对ICSR做专业评估。包括但不仅限于以下内容。- Identify reportable cases, evaluate cases in appropriate prioritization, and meet reporting timeline明确需要提交的报告，合理安排优先秩序对报告进行评估，符合报告时限。- Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labeledness); special scenarios; product complaint information; and etc.对下述内容进行审核，排序，核对，评估和存档：事件，报告类别（有效性，严重性，已知性），特殊情况，产品投诉信息，等等。- Write and edit the case narrative.撰写和编辑报告描述。· Consistently apply regulatory requirements and Pfizer policies.完全遵守法规要求和辉瑞政策。Technical Skill Requirements· Experience in pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement.具有以下经验者优先考虑：药物警戒，临床实践，临床或科学性研究。但不是必须。· Demonstrated computer literacy, particularly in the use and management of relational databases.熟练运用计算机，特别是有使用相关数据库经验者。 · Excellent oral and written communication skills.良好的口头和书面沟通能力。· Fluency in spoken and written English.流利英语口语和书写。Qualifications (i.e., preferred education, experience, attributes)· Bachelor’s degree in a science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification preferred.科学相关领域本科及以上，药学，护理，或同等学历；医务工作资质者优先考虑。· Ability, with supervision, to solve routine problems and to surface issues constructively. 能在指导下解决日常问题，并且建设性面对难题。· Ability to make basic decisions with an understanding of the consequences. 能在理解事情结果的情况下独立做决定 职能类别： 药品生产/质量管理 临床研究员

联系方式

光谷生物城

公司信息

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards. 辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。

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