[湖北]辉瑞中国武汉研发中心诚挚欢迎医药相关专业毕业生

日期:2011-07-01 来源:丁香园

辉瑞中国武汉研发中心诚挚欢迎医药相关专业毕业生

 

投递简历邮箱:RecruitmentR&DCenter.China@Pfizer.com

Position: Data Entry Associate (multiple openings of contractors)
Report to: Supervisor of Central Safety Data Entry Group
Department: Central Safety Data Entry Group, SER, WSRO
Location: Biolake, Wuhan

Position Summary

The Data Entry Associate of the Central Safety Data Entry Group performs individual case safety report (ICSR) data entry in Pfizer global safety database per standard operating procedures (SOPs) and associated guidelines and Safety Job Aids. The Data Entry Associate also implements and manages all quality check (QC) activities after the individual case safety report (ICSR) has been entered to ensure the accuracy of the data.
作为中心安全数据录入组的数据录入助理,主要依照标准操作流程、相关指导原则和安全工作指南执行辉瑞全球药物安全数据个人病例安全报告的数据录入工作, 确保数据录入的准确性,并负责质量控制工作。

Key Result Areas

ICSR Data Entry 个人病例药物安全报告数据录入
Perform initial and follow-up ICSR data entry within required timelines
在要求时间内完成原始和后续个人病例安全报告的数据录入
Performs adverse event (AE) and medical history coding within the safety database using medical coding dictionary
在安全数据库中,运用医学编码字典对不良事件和病史进行标准编码
Perform product coding per corporate SOP
依照公司相关标准操作流程对产品进行标准编码
Release cases within safety system to Product Safety Surveillance Reporting (PSSR) Therapeutic Teams
在安全数据系统中将案例发给药物安全监督与报告部各治疗组
Train on, understand and apply, all data entry guidelines as appropriate
通过培训,理解并适当应用所有数据录入相关指导原则
Develop a solid knowledge of the safety database and other applications as required
根据工作需要提高个人安全数据库和其他应用程序的知识
Communicate with other members of SER groups within Pfizer regarding data entry issues as required
如有需要,按要求就数据录入相关问题与安全评价与报告部的同事进行有效沟通

QC Review 质量监督检查
Review the case information in the Pfizer global safety database against the source document for accuracy of transcription
对照源文件,对辉瑞全球安全数据库的病例信息进行检阅以保证信息的准确性。
Correct any errors before release to PSSR
在数据被发送至药物安全监督与报告部之前确保数据的准确性
Meet with Supervisor and other colleagues in Central Safety Data Entry Group to review/discuss observations and/or corrective action(s) as appropriate
与主管或部门同事一起,对错误数据进行检查,讨论和纠正

Other Activities 其他
May contribute or assist with special projects, as requested
可能需要协助特定项目
Awareness and use of other applications as required
根据需要了解并使用其它应用程序
May contribute to appropriate continuous improvement initiatives
参与工作的持续改进活动

Qualification/Experience

Safety or clinical database experience is preferred
有安全或临床数据库操作经验者优先
Must have a Life Science Bachelor degree - Health Care Professional (HCP) is preferred
必须具备生命科学领域学士或以上学位,医学保健专业优先

Key Competencies

Excellent command of the English language, written and verbal
能熟练运动英语进行书面和口语交流
Able to communicate effectively with colleagues and associates.
能与合作伙伴、同事之间进行有效积极交流
Good understanding of medical terminology
能很好理解医学专业术语
Good time management and ability to work well under time constraints to meet reporting timelines.
有较强的时间管理能力,能在规定时间内完成工作
Excellent attention to detail
出色的细节关注能力
Strong analytical and organizational skills
具备较强的分析和组织能力
Ability to work effectively in a multi-cultural context
能在多元文化背景下进行有效的工作
Experience in electronic data processing in a scientific environment preferred
在科学环境中有电子数据处理经验者优先
Excellent knowledge of Microsoft office and general computer literacy
熟练掌握微软办公系统并对电脑熟识
High teamwork spirit
高度的团队合作精神

Position: Supervisor of Central Safety Data Entry Group (multiple
openings of contractors)
Report to: Manager of Central Safety Data Entry Group
Department: Central Safety Data Entry Group, SER, WSRO
Location: Biolake, Wuhan


Position Summary

The Supervisor of Central Safety Data Entry Group will perform all the responsibilities of a Data Entry Associate, including but not limited to
中心安全数据录入组主管承担所有数据录入助理的职能,其主要责任包含以下几点:
(1) perform individual case safety report (ICSR) data entry in Pfizer global safety database per standard operating procedures (SOPs) associated guidelines/Safety Job Aids
依照标准操作业程序、相关指导原则和安全工作指南负责执行辉瑞全球药物安全数据个人病例安全报告的数据录入工作
(2) implement and manage quality check (QC) activities after the ICSR has been entered to ensure the accuracy of the data for the team. In addition, the Supervisor will provide oversight of the ICSR data entry, day-to-day workload management, as well as other projects related to central safety data entry. The supervisor must have a good competency in a wide range of data entry and QC review activities. She/he will be responsible to assist the Head of Central Safety Data Entry Group with training activities for the team, e.g., company safety database, other various applications, assignment of mentors or serve as a mentor, monitor quality and timeliness to assure the quality and timely delivery of the data entry work.
在个人病例安全报告数据录入完成并保证数据的准确性后,负责执行和管理所有的质量检测。另外,主管将对个人病例安全报告的录入及其相关项目进行管理,并对日常工作量进行安排管理。主管必须在数据录入和质量检测等广泛领域拥有较高能力。她/他将负责协助中心安全数据录入负责人进行部门培训,如公司药物安全数据库等其他各种应用程序的运用,指定导师或担任导师职责,质量监管和在有效时间内进行高质量和及时的数据录入工作。


Key Result Areas

ICSR Data Entry个人病例药物安全报告数据录入:
Perform initial and follow-up ICSR data entry within required timelines
在要求时间内完成原始和后续个人病例安全报告的数据录入
Performs adverse event (AE) and medical history coding within the safety database using medical coding dictionary
在安全数据库中,运用医学编码字典对不良事件和病史进行标准编码
Perform product coding per corporate SOP
依照公司相关标准操作流程对产品进行标准编码
Release cases within safety system to Product Safety Surveillance Reporting Therapeutic Teams
在药物安全数据系统中将案例发给药物安全监督与报告部各治疗组
Train on, understand and apply, all data entry guidelines as appropriate
通过培训,理解并适当应用所有数据录入相关指导原则
Develop a solid knowledge of the safety database and other applications as required
根据工作需要提高个人安全数据库和其他应用程序的知识
Communicate with other members of SER groups within Pfizer regarding data entry issues as required
如有需要,按要求就数据录入相关问题与安全评价与报告部的同事进行有效沟通

QC Review 质量监督检查:
Review the case information in the Pfizer global safety database against the source document for accuracy of transcription
对照源文件,对辉瑞全球安全数据库的病例信息进行检阅以保证信息的准确性。
Correct any errors before release to PSSR
确保发给药物安全监督与报告部数据的准确性
Meet with colleagues in Central Safety Data Entry Group to review/discuss observations and/or corrective action(s) as appropriate
与部门同事一起,对错误数据进行检查,讨论和纠正
Share trends in QC review findings with Head of Central Safety Data Entry Group
分析在质量检查中发现的问题,与中心安全数据录入部门负责人及时沟通

Other Activities 其他:
May lead, contribute or assist with special projects, as requested
根据工作需要能够领导、协助特定项目
Excellent knowledge of safety database data entry and conventions
精通安全数据库数据录入技能
Awareness and use of other applications as required
根据工作需要了解并应用其他相关软件
May develop/lead/contribute to appropriate continuous improvement initiatives
能开展并领导持续性工作改进活动
Liaise appropriately with senior management regarding case timelineness and quality and resource management
对于病例的时间控制、质量控制和资源管理方面能与高层管理人员进行恰当的沟通

People Management
Participate in appropriate training pertinent to performance
参加相关培训并能够合理运用所学技能
Prioritize work assignments collaborating with the Head of Central Safety Data Entry Group
与安全数据录入部门负责人一起合作进行工作分配
Supervise workload and resources
管理工作量和资源
Ensure data entry quality of reports, files, and processes
管理报告、文件和数据录入的流程和质量
Ensure that all work is completed within company timelines and according to quality standards
确保所有工作在规定时间内高质量完成
Act as a resource to other team members and provide one-on-one support where appropriate
根据需求能为部门其他团队成员提供资源,并给予一对一的支持
Train and mentor new team members
指导和培训新同事


Qualification/Experience

Must have a Life Science Batchelor degree - Health Care Professional (HCP) is preferred
必须具备生命科学领域学士或以上学位,医学保健专业优先
Experience in electronic data processing in a scientific environment
具备科学环境中电子数据处理经验
High proficiency in using Windows and MS office and excellent keyboard skills
能熟练运用微软操作系统,并精通微软办公系统和键盘操作
Safety or clinical database experience is preferred
有安全或临床数据库操作经验者优先
One year supervisory experience desired
有一年以上的主管工作经验


Key Competencies

Demonstrated effective people management and resource management skills
具备有效的人员管理和资源管理技能
Excellent command of the English language, written and verbal
熟练的英语书面和口语交流能力
Able to communicate effectively with colleagues and associates
能与合作伙伴、同事之间进行有效积极交流
Good understanding of medical terminology
能很好理解医学专业术语
Strong competency in MedDRA coding
拥有较强的MedDRA编码能力
Good time management with the ability to work well under time constraints to meet reporting timelines
有较强的时间管理能力,能在规定时间内完成工作
Excellent attention to detail
优秀的细节关注能力
Strong analytical and organizational skills
较强的分析和组织能力
High teamwork spirit
具备高度的团队合作精神
Ability to work effectively in a multi-cultural context
能在多元文化背景下进行有效的工作

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