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Case Management - Manager
Tallahassee, FLDescription:
Note:
Remote
Shift/Schedules- Flex, normal dayshift hours
Title (Role) Case Management - Manager
Organization Global Patient Safety
Act as US/EU local safety office and FDA/EMA point of contact for safety reporting
Submission of all individual case safety reports to FDA/EMA, business partners (license partners) and vendors
Support interactions with, business partners (license partners) and vendors for all case intake and processing activities
Vendor oversight of all case intake processing activities and case quality including analysis and reporting of trends in quality measures
Ensure vendor compliance with approved processes and training requirements
Audit & external inspection support
Job Summary Responsible for:
Support ICSR processing to ensure high quality cases in a timely manner to meet all worldwide regulatory authority requirements
Provide vendors with resources and training to perform their role
Support the analysis and communication of case QC results
Lead development and delivery of training materials for case management conventions
Support resolution of case related specific queries
Management of multiple business partner relationships for case management
Support reviews of contract wording for case related data exchange
Monitoring 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
Escalation of 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
Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
Key Activities
Day-to-day vendor management issues
Interact with other local safety offices
Ensure case processing timelines for AE intake, triage and submission are met
Assess workload to assist in resource management
Support on-boarding and on-going training of vendors
Attend management meetings with vendors
Support analysis of QC trends
Support generating, communicating, and archiving of reports of QC findings
Support audits of CAPAs and other actions/recommendations for ICSR quality related measures
Perform case review as required
Lead development and delivery of convention-related training material
Support training of local office staff
Perform US case follow up activities
Perform BP reconciliation as required by safety agreement
Generate and distribute performance metrics (submission compliance, volumes, turnaround times)
Support reviews of contract wording for case related data exchange
Support regulatory inspection and support for vendor audits/inspections
Oversee performance monitoring and relay metrics to vendors
Support analysis of QC trends including actions/recommendations
Generate, communicate, and archive report of QC findings
Knowledge
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
Education & Experience (Basic)
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
Top 3 Must Have Skill Sets:
Pay Rate between $46- $53/Hr on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"
Note:
Remote
Shift/Schedules- Flex, normal dayshift hours
Title (Role) Case Management - Manager
Organization Global Patient Safety
Act as US/EU local safety office and FDA/EMA point of contact for safety reporting
Submission of all individual case safety reports to FDA/EMA, business partners (license partners) and vendors
Support interactions with, business partners (license partners) and vendors for all case intake and processing activities
Vendor oversight of all case intake processing activities and case quality including analysis and reporting of trends in quality measures
Ensure vendor compliance with approved processes and training requirements
Audit & external inspection support
Job Summary Responsible for:
Support ICSR processing to ensure high quality cases in a timely manner to meet all worldwide regulatory authority requirements
Provide vendors with resources and training to perform their role
Support the analysis and communication of case QC results
Lead development and delivery of training materials for case management conventions
Support resolution of case related specific queries
Management of multiple business partner relationships for case management
Support reviews of contract wording for case related data exchange
Monitoring 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
Escalation of 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
Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
Key Activities
Day-to-day vendor management issues
Interact with other local safety offices
Ensure case processing timelines for AE intake, triage and submission are met
Assess workload to assist in resource management
Support on-boarding and on-going training of vendors
Attend management meetings with vendors
Support analysis of QC trends
Support generating, communicating, and archiving of reports of QC findings
Support audits of CAPAs and other actions/recommendations for ICSR quality related measures
Perform case review as required
Lead development and delivery of convention-related training material
Support training of local office staff
Perform US case follow up activities
Perform BP reconciliation as required by safety agreement
Generate and distribute performance metrics (submission compliance, volumes, turnaround times)
Support reviews of contract wording for case related data exchange
Support regulatory inspection and support for vendor audits/inspections
Oversee performance monitoring and relay metrics to vendors
Support analysis of QC trends including actions/recommendations
Generate, communicate, and archive report of QC findings
Knowledge
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
Education & Experience (Basic)
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
Top 3 Must Have Skill Sets:
- 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.
"This posting is for Contingent Worker, not an FTE"