药物安全专员 Safety Data Management Specialist 武汉

月薪：

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： 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. Determination of local submission of individual and, where appropriate, aggregate safety reportsPrimary Responsibilities · 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 activitiesTechnical Skill Requirements· Experience in pharmacovigilance and/or data management preferred but not required· Experience and skill with medical writing an advantage· Demonstrated computer literacy· Experience in use and management of relational databases preferredQualifications (i.e., preferred education, experience, attributes)· Health Care Professional or equivalent experience 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· Fluency in spoken and written English 职能类别： 生物工程/生物制药 临床数据分析员

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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企业入驻日期： 2017-11-09

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