Taipei
Taipei - Northern Taiwan -
Taipei - Northern Taiwan -
DESKRIPSI PEKERJAAN
Position 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.
Primary Responsibilities
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
REQUIREMENT
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 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
DETAIL LOWONGAN
- Umur -
- Min GPA -
- Min. Qualification S1/D4
- Min Experience Staff
LOKASI KERJA
Alamat
Taipei