(Clinical Research) Operations Specialist临床研究药物安全专员
昆泰医药发展（上海）有限公司
- 公司规模：150-500人
- 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：2012-08-23
- 工作地点：上海
- 招聘人数：1
- 工作经验：一年以上
- 学历要求：本科
- 语言要求：英语熟练
- 职位类别：临床研究员 医药技术研发人员
职位描述
要求医药学相关专业背景，医药领域工作经验，有药物临床研究相关工作经验优先。
The world's leading pharmaceutical services organization is powering the next generation of healthcare. If you want to make a difference in global healthcare, Quintiles is the place for you. You'll be connected with an organization that is changing the way drugs are developed, profiled and marketed. More than 26,000 people throughout the world have already chosen to join Quintiles.
Of the world's top 30 best-selling drugs, Quintiles has helped to develop or commercialise every single one. This is an outstanding opportunity to join Quintiles and become an integral part of our team.
We are looking for suitable individuals to fill the position of:
RESPONSIBILITIES
？ Receive, triage, review and process Lifecycle Safety data from various sources on time, within budget and quality standards. Perform data entry for tracking and Lifecycle Safety databases, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. Pre-process material for endpoint committee or core laboratory adjudication. Preparation of material for submission of secondary review.
？ Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local Quintiles offices to facilitate expedited reporting. Liaise with systems manager for regulatory tracking requirements and electronic reporting.
？ Contribute to individual deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.
？ Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting Lifecycle Safety data.
？ Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.
？ Mentoring less experienced or newer staff members. May provide oversight on operational activities and have a sound understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects; set up and maintain project files, standards, templates, electronic forums, databases and workflow.
？ May provide oversight role to impart technical and process information to the LSM point of contact and members of operational team.
？ May provide an oversight role to perform operational and collaborative LSM tasks as directed by Lifecycle Safety Infrastructure.
？ Participate in team meetings and provide regular feedback to operations team manager and lifecycle safety management (LSM) on operational project metrics, out of scope work challenges/issues and successes.
？ Ensure compliance to Quintiles high quality standards and works with LSM constructively in a matrix framework to achieve project and customer deliverables.
？ Work with LSM constructively in a matrix framework to achieve project and customer deliverables.
？ Participate in training across Lifecycle Safety service offerings. Provide project-specific operational process training to junior team members, monitors and investigative site personnel, as appropriate.
？ Liaise with different functional team members, e.g. project management, clinical, data management, health care professionals e.g. investigators, medical monitors, site coordinators and designees to address operational project issues.
？ Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
？ Read and acknowledge all necessary Quintiles standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable.
？ Perform other duties as assigned.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
？ Excellent knowledge of Lifecycle Safety processes; willingness and aptitude to learn new skills across Lifecycle Safety service lines.
？ Good understanding of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, Standard Operating procedures (SOPs)
？ Proven ability to meet strict deadlines; manage competing priorities and changing demands.
？ Proven ability to follow instructions/guidelines, work independently and on own initiative.
？ Good understanding of operational metrics, productivity and initiatives.
？ Excellent attention to detail and accuracy and maintain consistently high quality standards.
？ Effective mentoring skills.
？ Excellent written and verbal communication and report writing skills.
？ Ability to be flexible and receptive to changing process demands.
？ Sound judgment; decision making skills.
？ Ability to work effectively on multiple projects simultaneously. Organize own workload and effectively time manage competing priorities.
？ Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
？ Bachelor’s Degree or educational equivalent in a Scientific or Healthcare discipline and 1 year’s experience of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management etc) or equivalent combination of education, training.
职位职责
？ 及时收集、整理、审阅和处理多种来源的数据，符合预算和质量标准；跟踪和安全数据库的数据录入；编写相关医学术语，撰写医学病历，提交案例相关查询，执行质量控制，协助数据校对，推进结束案例，协调翻译并确保报告在规定期限内发送至客户；预处理提交给终点委员会或核心实验室审查机构的材料；准备提交复审的材料。
？ 药物安全数据的评估以向有关部门报告的能力，跟踪可疑病例并报告至监管部门，伦理委员会，机构审查委员会，研究者，并在时间限定内按照符合要求的方式根据相应法规进行监督。联络当地的昆泰医药办公室促进完成迅速执行型报告。联络系统经理完成法规跟踪要求和电子汇报。
？ 独立完成安全信息发布、风险管理、安全监察、医学信息或其他服务内容等方面的工作。
？ 接听并记录从试验点或其他来源关于报告药物安全数据的电话、传真或电子邮件或其他材料报告。
？ 遵循国家有关规定、指导方针、标准操作规程(SOP)和项目的要求来处理药物安全数据。
？ 指导缺少经验或新进的员工。需监督营运性活动并提供合理的项目方案、治疗说明、项目预算和工作范围；建立和维护项目文件、标准、模板、电子讨论、数据库和工作流。
？ 可以作为监督角色传递技术及程序信息至药物安全的联络点和营运团队的成员。
？ 可以作为监督角色，根据药物安全部门的组织架构执行和配合完成管理团队分配的任务。
？ 参加团队会议，将操作性项目指标、超出工作范围的挑战/问题和成功反馈给营运团队经理和药物安全管理部门。
？ 确保与药物安全管理团队在同一个框架矩阵内进行建设性工作，依循昆泰医药的高质量要求完成项目并交付客户。
？ 联络不同职能的团队成员，如项目管理团队、临床医学团队、数据管理团队；联络专业医护人员，如调查员、医学监控人员、验点协调员和指定人员，共同解决项目相关问题。
？ 致力于帮助实现部门目标，例如，实现利用率和生产效率指标。
？ 阅读并确认所有必须文件包括昆泰医药的标准操作规程(SOP)和客户要求的标准操作规程(SOP)。确保及时完成所有必须的培训，并以文档形式记录。努力确保个人培训计划的实施并核对成绩单。
？ 执行其他被分配到的职责。
知识、技能和能力要求
？ 英语听说读写精通
？ 熟练掌握药物安全相关流程的知识。具有意愿倾向学习药物安全服务领域的新技能。
？ 能够良好的理解国际性法规、地区性法规和当地临床法规及要求，例如：临床试验管理规范（GCP）、人用药品注册技术要求国际协调会议（ICH）、标准操作规程(SOP)。
？ 能够严格按规定时间完成工作；合理安排工作的优先顺序，应对不断变化的需求。
？ 能够遵循说明/指导独立并积极主动工作。
？ 能够良好的理解营运性指标，生产率和主观能动性。
？ 能够高度关注细节及精确，持续保持高质量标准。
？ 良好高效的指导能力。
？ 出色的书面及口头表达能力和撰写报告技巧。
？ 能够灵活接受不断变化的工作要求。
？ 良好的判断能力和决策能力。
？ 能够对多个项目同时进行有效地工作，协调工作强度、高效管理时间和优先顺序。
？ 能够与同事、领导和客户建立并保持高效的工作关系。
最低学历及工作经验要求
？ 本科学历或其他同等学历，科学/医疗保健专业教育背景，并拥有一年以上药物安全相关工作经验（药物安全警戒，CEVA，医疗信息，安全信息发布，风险管理等）或接受同等教育和培训经验。
The world's leading pharmaceutical services organization is powering the next generation of healthcare. If you want to make a difference in global healthcare, Quintiles is the place for you. You'll be connected with an organization that is changing the way drugs are developed, profiled and marketed. More than 26,000 people throughout the world have already chosen to join Quintiles.
Of the world's top 30 best-selling drugs, Quintiles has helped to develop or commercialise every single one. This is an outstanding opportunity to join Quintiles and become an integral part of our team.
We are looking for suitable individuals to fill the position of:
RESPONSIBILITIES
？ Receive, triage, review and process Lifecycle Safety data from various sources on time, within budget and quality standards. Perform data entry for tracking and Lifecycle Safety databases, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. Pre-process material for endpoint committee or core laboratory adjudication. Preparation of material for submission of secondary review.
？ Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local Quintiles offices to facilitate expedited reporting. Liaise with systems manager for regulatory tracking requirements and electronic reporting.
？ Contribute to individual deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.
？ Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting Lifecycle Safety data.
？ Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.
？ Mentoring less experienced or newer staff members. May provide oversight on operational activities and have a sound understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects; set up and maintain project files, standards, templates, electronic forums, databases and workflow.
？ May provide oversight role to impart technical and process information to the LSM point of contact and members of operational team.
？ May provide an oversight role to perform operational and collaborative LSM tasks as directed by Lifecycle Safety Infrastructure.
？ Participate in team meetings and provide regular feedback to operations team manager and lifecycle safety management (LSM) on operational project metrics, out of scope work challenges/issues and successes.
？ Ensure compliance to Quintiles high quality standards and works with LSM constructively in a matrix framework to achieve project and customer deliverables.
？ Work with LSM constructively in a matrix framework to achieve project and customer deliverables.
？ Participate in training across Lifecycle Safety service offerings. Provide project-specific operational process training to junior team members, monitors and investigative site personnel, as appropriate.
？ Liaise with different functional team members, e.g. project management, clinical, data management, health care professionals e.g. investigators, medical monitors, site coordinators and designees to address operational project issues.
？ Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
？ Read and acknowledge all necessary Quintiles standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable.
？ Perform other duties as assigned.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
？ Excellent knowledge of Lifecycle Safety processes; willingness and aptitude to learn new skills across Lifecycle Safety service lines.
？ Good understanding of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, Standard Operating procedures (SOPs)
？ Proven ability to meet strict deadlines; manage competing priorities and changing demands.
？ Proven ability to follow instructions/guidelines, work independently and on own initiative.
？ Good understanding of operational metrics, productivity and initiatives.
？ Excellent attention to detail and accuracy and maintain consistently high quality standards.
？ Effective mentoring skills.
？ Excellent written and verbal communication and report writing skills.
？ Ability to be flexible and receptive to changing process demands.
？ Sound judgment; decision making skills.
？ Ability to work effectively on multiple projects simultaneously. Organize own workload and effectively time manage competing priorities.
？ Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
？ Bachelor’s Degree or educational equivalent in a Scientific or Healthcare discipline and 1 year’s experience of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management etc) or equivalent combination of education, training.
职位职责
？ 及时收集、整理、审阅和处理多种来源的数据，符合预算和质量标准；跟踪和安全数据库的数据录入；编写相关医学术语，撰写医学病历，提交案例相关查询，执行质量控制，协助数据校对，推进结束案例，协调翻译并确保报告在规定期限内发送至客户；预处理提交给终点委员会或核心实验室审查机构的材料；准备提交复审的材料。
？ 药物安全数据的评估以向有关部门报告的能力，跟踪可疑病例并报告至监管部门，伦理委员会，机构审查委员会，研究者，并在时间限定内按照符合要求的方式根据相应法规进行监督。联络当地的昆泰医药办公室促进完成迅速执行型报告。联络系统经理完成法规跟踪要求和电子汇报。
？ 独立完成安全信息发布、风险管理、安全监察、医学信息或其他服务内容等方面的工作。
？ 接听并记录从试验点或其他来源关于报告药物安全数据的电话、传真或电子邮件或其他材料报告。
？ 遵循国家有关规定、指导方针、标准操作规程(SOP)和项目的要求来处理药物安全数据。
？ 指导缺少经验或新进的员工。需监督营运性活动并提供合理的项目方案、治疗说明、项目预算和工作范围；建立和维护项目文件、标准、模板、电子讨论、数据库和工作流。
？ 可以作为监督角色传递技术及程序信息至药物安全的联络点和营运团队的成员。
？ 可以作为监督角色，根据药物安全部门的组织架构执行和配合完成管理团队分配的任务。
？ 参加团队会议，将操作性项目指标、超出工作范围的挑战/问题和成功反馈给营运团队经理和药物安全管理部门。
？ 确保与药物安全管理团队在同一个框架矩阵内进行建设性工作，依循昆泰医药的高质量要求完成项目并交付客户。
？ 联络不同职能的团队成员，如项目管理团队、临床医学团队、数据管理团队；联络专业医护人员，如调查员、医学监控人员、验点协调员和指定人员，共同解决项目相关问题。
？ 致力于帮助实现部门目标，例如，实现利用率和生产效率指标。
？ 阅读并确认所有必须文件包括昆泰医药的标准操作规程(SOP)和客户要求的标准操作规程(SOP)。确保及时完成所有必须的培训，并以文档形式记录。努力确保个人培训计划的实施并核对成绩单。
？ 执行其他被分配到的职责。
知识、技能和能力要求
？ 英语听说读写精通
？ 熟练掌握药物安全相关流程的知识。具有意愿倾向学习药物安全服务领域的新技能。
？ 能够良好的理解国际性法规、地区性法规和当地临床法规及要求，例如：临床试验管理规范（GCP）、人用药品注册技术要求国际协调会议（ICH）、标准操作规程(SOP)。
？ 能够严格按规定时间完成工作；合理安排工作的优先顺序，应对不断变化的需求。
？ 能够遵循说明/指导独立并积极主动工作。
？ 能够良好的理解营运性指标，生产率和主观能动性。
？ 能够高度关注细节及精确，持续保持高质量标准。
？ 良好高效的指导能力。
？ 出色的书面及口头表达能力和撰写报告技巧。
？ 能够灵活接受不断变化的工作要求。
？ 良好的判断能力和决策能力。
？ 能够对多个项目同时进行有效地工作，协调工作强度、高效管理时间和优先顺序。
？ 能够与同事、领导和客户建立并保持高效的工作关系。
最低学历及工作经验要求
？ 本科学历或其他同等学历，科学/医疗保健专业教育背景，并拥有一年以上药物安全相关工作经验（药物安全警戒，CEVA，医疗信息，安全信息发布，风险管理等）或接受同等教育和培训经验。
公司介绍
ABOUT THE COMPANY
Quintiles Transnational Corp. strives unceasingly to exercise strong LEADERSHIP in our industry and to be the unquestioned FIRST CHOICE Contract Pharmaceutical Organization in an increasingly competitive marketplace.
We will DELIGHT our CUSTOMERS world-wide with the fullest range and highest quality of information and services, and with a spirit and a DEDICATION that bring professional esteem and admiration.
We demand the utmost level of EXCELLENCE, CREATIVITY, and SKILL from all our staff and management so that we add value to our customers by driving to PERFORMANCE goals in ways that are quantifiable.
We thrive on continuous IMPROVEMENT and QUALITY enhancements through attention to detail,consistent feedback, state-of-the-art systems, TRAINING and TEAMWORK.
We seek unendingly to bring our customers'PRODUCTS and SERVICES to MARKET ever sooner and to play a creative role in their achievement of earlier and greater commercial SUCCESS.
Throughout our commercial pursuits, we will respect and hold in esteemed honor our EMPLOYEES, to whom we owe our very existence.
We will maintain and enhance our reputation and integrity by demanding the highest possible ETHICAL STANDARDS and demonstrate by example an unyielding dedication to employees, customers, vendors, and shareholders. A SHARED VISION of success among these stakeholders will enhance the quality of life for all people of the world as we vigorously pursue our mission in an era of unprecedented OPPORTUNITY
Quintiles Transnational Corp. strives unceasingly to exercise strong LEADERSHIP in our industry and to be the unquestioned FIRST CHOICE Contract Pharmaceutical Organization in an increasingly competitive marketplace.
We will DELIGHT our CUSTOMERS world-wide with the fullest range and highest quality of information and services, and with a spirit and a DEDICATION that bring professional esteem and admiration.
We demand the utmost level of EXCELLENCE, CREATIVITY, and SKILL from all our staff and management so that we add value to our customers by driving to PERFORMANCE goals in ways that are quantifiable.
We thrive on continuous IMPROVEMENT and QUALITY enhancements through attention to detail,consistent feedback, state-of-the-art systems, TRAINING and TEAMWORK.
We seek unendingly to bring our customers'PRODUCTS and SERVICES to MARKET ever sooner and to play a creative role in their achievement of earlier and greater commercial SUCCESS.
Throughout our commercial pursuits, we will respect and hold in esteemed honor our EMPLOYEES, to whom we owe our very existence.
We will maintain and enhance our reputation and integrity by demanding the highest possible ETHICAL STANDARDS and demonstrate by example an unyielding dedication to employees, customers, vendors, and shareholders. A SHARED VISION of success among these stakeholders will enhance the quality of life for all people of the world as we vigorously pursue our mission in an era of unprecedented OPPORTUNITY