Description
Primary Responsibilities- 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, including Clinical Development, License Partners, and other 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.
QUALIFICATIONS:
- Healthcare professional is required, licensed nurses or pharmacists preferred.
- Safety case processing experience.
- 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 BSN, Rph, or PharmD 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 1 year contract.
- 4-7 years of experience in Quality Assurance and Quality Control required