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无工作经验 -
本科 -
招若干人 -
11-09 发布
职位描述
职位描述： Organizational Relationship(s) including to whom the position reports (JD Job Title):Reports to Therapeutic Area Team LeadPosition PurposeReview, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer’s products and to meet regulatory requirements.Primary Responsibilities · Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays. · Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately.· Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labeledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly. · Review case criteria to determine the appropriate workflow for case processing.· Write and edit the case narrative.· Generate reports, ensuring adherence to regulatory compliance timelines. · Determine and perform appropriate case follow-up, generating and requesting follow-up letters. · Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation. · Develop and maintain expertise and knowledge of: all assigned products within a therapeutic area; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database. · Consistently apply regulatory requirements and Pfizer policies.Technical Skill Requirements· Experience in pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement.· Demonstrated computer literacy, particularly in the use and management of relational databases. · Ability to achieve personal objectives while meeting departmental standards of performance.· Ability to work under supervision in a matrix organization.· Excellent oral and written communication skills.· Fluency in spoken and written English; knowledge of additional language(s) an advantage.· Experience and skill with medical writing an advantage.Qualifications (i.e., preferred education, experience, attributes)· Ability, with supervision, to solve routine problems and to surface issues constructively. · Ability to make basic decisions with an understanding of the consequences. · Bachelor’s degree in a science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification preferred. 职能类别： 临床数据分析员 生物工程/生物制药
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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