Case Management Specialist

2 days ago


Tallahassee, United States ADVANCED BIO-LOGIC SOLUTIONS Full time
Job Summary

As a Case Management Specialist at Advanced Bio-Logic Solutions, you will be responsible for ensuring high-quality case processing and timely submission to meet worldwide regulatory authority requirements. You will provide vendors with resources and training to perform their role, support the analysis and communication of case QC results, and lead the development and delivery of training materials for case management conventions.

Key Responsibilities
  • Support ICSR processing to ensure high-quality cases in a timely manner
  • Provide vendors with resources and training to perform their role
  • Support the analysis and communication of case QC results
  • Lead the development and delivery of training materials for case management conventions
  • Support resolution of case-related specific queries
  • Manage multiple business partner relationships for case management
  • Support reviews of contract wording for case-related data exchange
  • Monitor compliance in regard to regulatory submissions and/or contractual wording for data exchange
  • Assign tasks within Case Management to direct and indirect reports
  • Support management of staff within Case Management
  • Escalate case processing issues
  • Audit & external inspection support
  • Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
  • Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
Requirements
  • Master's degree and 3 years of directly related experience
  • Bachelor's degree and 5 years of directly related experience
  • Associate's degree and 10 years of directly related experience
  • High school diploma / GED and 12 years of directly related experience
  • Previous experience directly managing teams, projects, programs or directing the allocation of resources
Preferred Skills
  • Understanding of global regulatory requirements for pharmacovigilance
  • Project leadership experience
  • Competence in safety systems
  • Experience in supporting inspections or internal audits
  • Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook
Pay Rate

Between $46- $53/Hr on W2 based on experience.



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