VIGILARE'S CUSTOMERS derive great results from Integrated Drug Safety and Pharmacovigilance Services:

Consulting and Quality Assurance Services:

  • Inspection Readiness
  • QA Audits
  • CAPA Creation, Tracking and Management
  • GAP Analysis and Suggested Remediation
  • Transformational Change Management
  • Systems Validation
  • Due Diligence 

Medical Information and Product Contact Center:

 Inbound and Outbound- Web and Telephony Services

  • Medical Information Inquiry
  • Tracking
  • Documentation
  • Fulfillment
  • Adverse Event Contact Intake and Follow-up
  • Product Quality Complaint
  • Report Tracking
  • Transfer
  • Patient Outreach
  • Patient Contact Programs

Adverse Event Processing: 

  • Complete a Partial ICSR Management
    •  Case Receipt and Data Entry
    • MedDRA,  WHO-Drug Dictionary Coding
    • Narrative Writing
    • Quality Control
    • Assessment and Medical Review
    • Submission of Reports to Health Authorities and Stakeholder 
    • Health Authority Liaison

Risk Management and Aggregate Reporting: 

  • Periodic Safety update Reports (PSURs/PBRERs)
  • Periodic Adverse Experience Reports (PADERs)

  • Development Safety Update Reports (DSUR)

  • Review of Line Listing

  • Signal Detection Activities

  • Regulatory Interactions and Product Support

  • Risk Management Plans/REMS 

Operational Approaches

Turnkey Pharmacovigilance Processes & Systems

  • Fully validated database
  • Full set of SOP’s
  • All Staffing is provided and managed via Key Performance Indicators
  • Detail QA Plan
  • CAPA

Staffing Model  

Vigilare provides experience pharmacovigilance staff to work within clients system

  • ARGUS and/or ARISg experience
  • Managed and directed by client’s PV management
  • Staff trained on client SOP’s and systems

Hybrid Approach

  • Combine Turnkey and Staffing model
  • Custom solution based upon client needs