職位描述
職位描述：
工作職責(zé)：
PURPOSE
Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer’s products and to meet regulatory requirements. Determination of local submission of individual and, where appropriate, aggregate safety reports.
AREAS OF RESPONSIBILITY
？ 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 the appropriate workflow for case processing
？ Assess cases to distinguish those with particular complexities andor specific issues, and escalate appropriately
？ Write and edit the 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
？ Supporting Inspection Readiness as needed
任職資格：
MINIMUM REQUIREMENTS 最低要求
EDUCATION 教育程度
Bachelor degree, medical pharmacy or bio-science background is preferred.
Experience 經(jīng)驗(yàn)
2 years working experience, more than 1 year working experience in pharmaceutical companies on data management, PV or clinical research field
SPECIFIC KNOWLEDGE 特殊知識
？ 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 reading and written English
Competencies 技能
？ Experience and skill with medical writing an advantage
？ Demonstrated computer literacy
？ Experience in use and management of relational databases preferred
