长沙招聘

• Position Purpose
  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
  
  Primary 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 appropriate workflow for case processing
  Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
  Write and edit 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
  
  
  
• 任职资格：Technical 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 preferred
  
  
  Qualifications (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

   clinical medicine, pharmacy, nursing, or equivalent; healthcare professional qualification is required

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。