Satefy Assessor （临床安全信息评估员）
辉瑞（中国）研究开发有限公司
- 公司规模：10000人以上
- 公司性质：外资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2012-11-13
- 工作地点：上海
- 招聘人数：1
- 工作经验：三年以上
- 学历要求：本科
- 语言要求：英语精通
普通话精通 - 职位类别：医药技术研发人员 药品注册
职位描述
Position Summary:
The Safety Assessor will be responsible for performing clinical assessment, preparaing, and completing reports of adverse drug experiences.
Main Responsibilities:
? Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, listedness); 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.
? 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.
? Consistently apply regulatory requirements and Pfizer policies.
? Develop and maintain knowledge of: applicable corporate and global regulations, guidelines, and Standard Operating Procedures; data entry conventions and search functions in the safety database.
? Develop expertise on the assigned products within a therapeutic area.
Qualification/Experience Requirement:
? medical, pharmacology/pharmacy, or other bioscience related bachelor degree
? pharmaceutical industry experience in the area of pharmacovigilence, clinical data management, or regulatory affairs preferred
? clinical practice an advantage
Key Competency Requirements:
? Excellent mastery of English, both written and verbal, able to communicate effectively
? Good understanding of ICH guidelines, regulatory requirements and clinical quality assurance
? Strong clinical background and good grasp of medical terminology
? Excellent mastery of Microsoft office tools and typing skills
? Ability to manage multiple priorities within timeframe
? Good time-management, sense of urgency
? Fast learner, customer focused
? Ability to work effectively in a multi-cultural context and work from a distance with colleagues in different country/region operations
? Ability, with supervision, to solve routine problems and surface issues constructively
? Ability to make basic decisions with an understanding of the consequences.
? Excellent attention to accuracy and details
? Experience and skill with medical writing an advantage.
The Safety Assessor will be responsible for performing clinical assessment, preparaing, and completing reports of adverse drug experiences.
Main Responsibilities:
? Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, listedness); 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.
? 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.
? Consistently apply regulatory requirements and Pfizer policies.
? Develop and maintain knowledge of: applicable corporate and global regulations, guidelines, and Standard Operating Procedures; data entry conventions and search functions in the safety database.
? Develop expertise on the assigned products within a therapeutic area.
Qualification/Experience Requirement:
? medical, pharmacology/pharmacy, or other bioscience related bachelor degree
? pharmaceutical industry experience in the area of pharmacovigilence, clinical data management, or regulatory affairs preferred
? clinical practice an advantage
Key Competency Requirements:
? Excellent mastery of English, both written and verbal, able to communicate effectively
? Good understanding of ICH guidelines, regulatory requirements and clinical quality assurance
? Strong clinical background and good grasp of medical terminology
? Excellent mastery of Microsoft office tools and typing skills
? Ability to manage multiple priorities within timeframe
? Good time-management, sense of urgency
? Fast learner, customer focused
? Ability to work effectively in a multi-cultural context and work from a distance with colleagues in different country/region operations
? Ability, with supervision, to solve routine problems and surface issues constructively
? Ability to make basic decisions with an understanding of the consequences.
? Excellent attention to accuracy and details
? Experience and skill with medical writing an advantage.
公司介绍
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。
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。
联系方式
- Email：ChinaCPWTalent@Pfizer.com
- 公司地址：1 (邮编：200000)