Description
Role ResponsibilitiesIdentify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays.
Review, rank, verify, process and document: event terms; case classifications (validity, seriousness) special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly.
Review case criteria to determine the appropriate workflow for case processing.
Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
Write and edit the case narrative.
Determine and perform appropriate case follow-up, generating follow-up letters
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 company policies
Role qualifications
Ability, with supervision, to solve routine problems and to surface issues constructively
Ability to make basic decisions with an understanding of the consequences
Experience in Pharmacovigilance, and with the Argus Safety database, is essential
Demonstrated computer literacy, particularly in the use and management of relational databases
Ability to achieve personal objectives while meeting departmental standards of performance
Ability to work under supervision in a matrix organization
Experience and skill with medical writing an advantage
A BSc is essential.