Case Management - Manager

Remote

• bill rate for this role is *** to ***/hour to *** MAX
  
  

Shift/Schedules- Flex, normal dayshift hours

Title (Role) Case Management - Manager

Organization Global Patient Safety

Intake Call Notes with HM:

• What are the exact shift hours/schedule the contractor will be working? (What time will they be expected to be reporting online Monday-Friday) – align with 9:00-5:00 working hours in their time zone (8 hour work day)
• What type of qualities/characteristics are you looking for in candidates to work best with your team? Proactive, communicative, self-starter
• When reviewing resumes, what stands out to you when looking for the right applicants? Experience, previous roles in PV/Safety
• What is your minimum education and experience requirements you think it suitable for this role? Any certain industry you have a preference on seeing experience within? PV and Safety, Minimum 2 years of experience
• 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 and 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

OR

Bachelor’s degree and 5 years of directly related experience

OR

Associate’s degree and 10 years of directly related experience

OR

High school diploma / GED and 12 years of directly related experience

AND

Previous experience directly managing teams, projects, programs or directing the allocation of resources