药物安全专员 Safety Data Management Specialist
辉瑞中国NanchangUpdate time: August 17,2019
Job Description
- 招聘类型:社招
- 工作性质:全职
职位描述
- Carry out case processing activities
- Review, rank, verify, process and document case-related information: event terms
validity, seriousness, special scenarios
timelines
accuracy and consistency. Process cases based on these assessments
- Review case criteria to determine appropriate workflow for case processing
- Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
- Write and edit case narrative
- Determine and perform appropriate case follow-up, including generation of follow-up requests
- Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios
- Liaise with key partners, locally , and other stakeholders regarding safety data collection and data reconciliation
- Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database
- Determine reportability of scheduled reports , ensuring adherence to regulatory requirements
- Consistently apply regulatory requirements and Pfizer policies
- Participate, as appropriate, in local, internal and external safety activities
任职条件
Technical Skill Requirements
- Experience in pharmacovigilance and/or data management preferred but not required
- Experience and skill with medical writing an advantage
- Demonstrated computer literacy
- Experience in use and management of relational databases preferred
Qualifications (i.e., preferred education, experience, attributes)
- Health Care Professional or equivalent experience preferred
- Ability, with supervision, to solve routine problems and to surface issues constructively
- Ability to make basic decisions with an understanding of the consequences
- Ability to achieve personal objectives while meeting departmental standards of performance
- Ability to work under supervision in a matrix organization
- Fluency in spoken and written English
职位要求
- 学历要求:无
- 工作经验:无
- 外语要求:不需要
Get email alerts for the latest"药物安全专员 Safety Data Management Specialist jobs in Nanchang"
