长沙招聘

Job Title: Publishing and Product License Support Intern (CRDC)

Dept.: Publishing and Product License Support (PPLS)

Term: at least 6 Months

Vacancy: 1

 

General Job Description:

• Support Safety calls for contribution received for various Aggregate Safety Reports and collect correlative information to facilitate Global Regulatory Leads’ review and PSSR Analyst’s contributions.
• Delivery of electronic regulatory transactions and post market scheduled regulatory compliance activities in accordance with 21CFR 314.81 and 21CFR 314.80 via Pfizer submission management tools and systems.
• Responsible for managing tracking and preparation of post-marketing Annual Report (NDA AR) that are submitted to the U.S. Food and Drug Administration within agreed timelines.
• Other business needs to ensure business compliance

 

 

Job Requirements:

 

• University student, preferably majoring in Pharmacy, Biology, Life Science, Business or Information Technology or other related fields;
• In depth knowledge of drug development and regulation;
• Fluent in English listening, reading, writing and speaking;
• Computer literacy in MS Word/Outlook/Excel/Adobe Acrobat;
• Proven technical aptitude and ability to quick learn and use new soft wares, regulations and quality standards;
• Ability to work with accuracy and attention to details;
• Quick learner with ability to multi-tasks;
• Preferred to work at least 4 full days a week;
• Internship duration: at least 6 months.

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。