长沙招聘

职位描述：
Position Purpose
Individual filling the position are responsible for the project management of safety aggregate reports submitted to regulators that include the FDA and EMA. The incumbent will partner with various colleagues from safety, clinical, regulatory and other functional lines to produce the aggregate reports and ensure that these reports are completed in a timely manner meeting regulatory compliance.

Primary Responsibilities
? Lead report preparation from prep to submission with key stakeholders/contributors within Clinical, Regulatory, Safety, DevOps, Submissions, etc.
? Review data to ensure consistency between various contributors.
? Compile the information for reports using various electronic tools and document management system.
? Coordinate the review and approval of the report and address review comments.
? Ensure reports are completed prior to regulatory due date to meet compliance.
? Provide guidance to contributor regarding report requirements.
? Participate projects or subject matter tasks that support the group and deliverables.
? Participate in developing and performing User Acceptance Testing (UAT) as required.
? Complete training in accordance with Pfizer’s and WSR Safety information Management curriculum.

Technical Skill Requirements
? Experience in the pharmaceutical industry, clinical research, or healthcare related field.
? Experience with Microsoft word & excel, Adobe acrobat, ISI Toolbox, etc.
? Experience with SharePoint technology (e.g., Microsoft InfoPath, SharePoint Designer, etc.)
? Business Objects experience is a plus.

Qualifications (i.e., preferred education, experience, attributes)
? Bachelor’s Degree in life sciences, healthcare, or pharmaceutical discipline required.
? Excellent English verbal, written communication and presentation skills required.
? Must be detailed oriented.
? Strong project management and issue resolution skills required.
? Demonstrated ability to perform in a cross-functional environment.
? Knowledge of regulatory/safety regulations and guidelines desired. 举报 分享

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。