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1年经验 -
本科 -
招若干人 -
11-09 发布
职位描述
职位描述： 岗位职责： · Perform single case medical assessment, including the determination of seriousness, expectedness/listedness/labeledness, and causality of adverse events in compliance with current regulations, internal and external guidance documents, Standard Operating Procedures, Safety Job Aids, the Argus User Reference Guide and case processing/coding conventions. · Maintain the timely submission of expedited reports. · Support the achievement of the Therapeutic Area’s case processing performance timelines. Identify cases that meet SUSAR reporting criteria, prepare the SUSAR narrative, perform risk assessment, initiate the unblinding process (as appropriate), and make the report available for distribution. · Identify and evaluate safety signals based on individual cases and cumulative data assessment and by using other signal detection systems. Provide data-driven decisions and communicate these findings proactively and effectively to the key stakeholders. · Partner with Safety Surveillance and Risk Management and with other Worldwide Safety and Regulatory functional groups to monitor the safety profile of assigned products. · Actively participate in Risk Management Committees and other risk management activities for assigned therapeutic areas. Perform product safety reviews as appropriate. · Provide medical safety input as appropriate to Clinical Development Teams regarding expectedness/listedness/labeledness, causality, and data reconciliation. · As appropriate, provide medical safety input, and review or draft sections of response documents to health authority inquiries. · Work with the Therapeutic Area Head and Medical Review Head to proactively and effectively communicate product safety issues and proposed solutions to PSSR management and to the Office of the EU Qualified Person. · Provide timely review of and input to documents, including labeling, protocols, Investigator Brochure, and licensing agreements. · Provide timely input into product related milestones. · Provide medical input, review and analysis of Periodic Safety Update Reports, Expert Statements, Risk Management Plans, and other aggregate reports; where appropriate, draft components of these reports. Ensure accurate, relevant, and meaningful ICSR data and insights. · Provide medical advice and insights to Therapeutic Area colleagues to improve the quality, consistency, accuracy, and clinical relevance of safety reports. · Support PSSR Quality Assurance activities, addressing observations related to medical assessment, as appropriate. Ensure consistency and quality of the medical assessment process. · Provide drug safety support when appropriate to product acquisitions, recalls, and legal issues. · Take responsibility for inspection readiness for medical assessment activities; support regulatory authority inspections when needed. · Proactively communicate with and engage Therapeutic Area colleagues and key stakeholders (e.g., Clinical Development Teams, Regulatory Affairs, Licensing, Manufacturing, and Marketing) to support business objectives and to discuss and resolve safety issues. · Engage internal and external customers with a sense of urgency and an appreciation of their needs and point of view. · As an individual contributor, initiate and/or take a leadership role in projects/process improvements that align with PSSR and/or SER strategic objectives. · Develop and maintain comprehensive and current knowledge (e.g., indications, labeling documents, pharmacology) for the assigned product portfolio. · Develop and maintain a comprehensive working knowledge of current regulations governing the processing and reporting of safety data, Standard Operating Procedures, Safety Job Aids, and case processing/coding conventions, consistently completing curriculum training by the specified due dates. · Utilize the corporate performance management process to manage goal setting and individual development. Consistently demonstrate Pfizer Values and Leader Behaviors. · Proactively mentor Therapeutic Area colleagues to foster an environment of trust, understanding, learning, and development. · Contribute to the mentoring and on-boarding of new PSSR colleagues 任职要求： · Demonstrated computer literacy, with proficiency in the use and management of safety databases, including the Pfizer Global Safety Database, Argus Safety, and MS Window, Excel, Word and Outlook · Ability to achieve personal objectives while meeting departmental standards of performance · Fluency in oral and written English; knowledge of additional language(s) an advantage · Experience and skill with medical writing an advantage · Medical Degree from an accredited institution · One to two years of experience as an MD in clinical practice · One to two years of relevant experience in pharmacovigilance, clinical research or related field · Pharmaceutical industry experience preferred · Working knowledge of international regulations and guidance documents as related to worldwide reporting requirements, preparation of clinical trial safety assessments, and regulatory submissions including the preparation of aggregate reports 职能类别： 医药技术研发管理人员 医药技术研发人员
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。
