Description
Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays.Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately.
Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labelledness); 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.
Write and edit the case narrative.
Generate reports, ensuring adherence to regulatory compliance timelines.
Determine and perform appropriate case follow-up, generating and requesting follow-up letters.
Liaise with key partners and stakeholders regarding safety data collection and data reconciliation.
Develop and maintain expertise and knowledge of: all assigned products within a therapeutic area; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database.
Consistently apply regulatory requirements and policies.
SKILLS:
Healthcare Professional is Required.
Clinical experience and drug safety experience in the pharmaceutical industry is highly desired.
Manager would prefer clinical experience outside of educational rotations (ie clinical experience after completing degree).
Critical thinking skills, process and compliance focused, solid writing skills.
Candidates must have demonstrated ability to prioritize and multi-task effectively while adhering to world-class standards of quality.
Quality Assurance.
Quality Control.