苏州招聘

Position Title: Dictionary Specialist

Zone / Line: Clinical Data Service (CDS), China Research and Development Center (CRDC)
Location: Shanghai, China

Position Purpose:
The Dictionary Specialist will support and maintain all business related activities regarding Pfizer standard medical dictionaries and is the single point of accountability in CDS for dictionary activities and deliverables. The Dictionary Specialist will ensure the quality and consistency of dictionary data towards the ultimate objective of data quality and consistency across programs and systems.

Primary Duties:
Perform Coding, Quality Control and Dictionary Quality Management review of Pfizer standard Dictionaries such as MedDRA and WHODrug

Function as Dictionary Subject Matter Expert to provide guidance for all Dictionary related issues and strategies within the corporation

Assist project and safety teams in the input/output of clinically coded terms

Ensure that Dictionary Services activities comply with relevant global regulatory requirements, relevant SOPs, and Pfizer coding guidelines & conventions

Consistently meet/exceed customer services standards by ensuring prompt & accurate completion of all Dictionary Services needs & requests by customers

Responsible for all creation and maintenance of Dictionary Services documentation

Responsible for the business activities supporting implementation or integration of Dictionary systems or those systems integrated with Dictionary Systems

Manage data integration activities such as dictionary data mapping and migration

Develop and Implement processes, metrics & other measures to ensure compliance with Dictionary Services standard, guidelines & conventions

Training & Education Preferred:
A minimum of a Bachelor’s degree in a Medical Science, Nursing, or Pharmacy with proficiency in English.

Prior Experience Preferred:

The candidate will have working experience of standard medical dictionaries used in pharmaceutical research or patient care data.

Prior clinical trial data management experience with a strong understanding of the business processes of drug development.

Strong working knowledge of anatomy, physiology, disease states, medical treatments and procedures, medication names and drug therapy, as well as thorough familiarity with medical terminology

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。