Pharmacovigilance

Our Pharmacovigilance Professionals offer Global and Local PV Services.

PV system

Our Pharmacovigilance Professionals offer Global and Local PV Services. We have developed a pharmacovigilance system to perform both global and local PV activities. Whether you need specialized service or full PV services, we can support it.

PV responsible person

We can offer you qualified and experienced EU Qualified Person for Pharmacovigilance (QPPV) and/or EU QPPV deputy and local QPPV/local PV contact person and/or deputy.

Our services include:

  • EU QPPV and/or deputy
  • Local QPPV/local PV contact person and/or deputy
  • 24/7 availability
  • PV system establishment and maintenance
  • Pharmacovigilance System Master File (PSMF) development and maintenance
  • Global and Local Literature Monitoring
  • Individual Case Safety Reports (ICSR) Management
  • Aggregate Safety Reports generation and reporting
  • Risk Management Plan (RMP) development and maintenance
  • Signal Management
  • Direct Healthcare Professional Communication (DHPC) management
  • Risk Minimization Measures (RMM) management
  • Regulatory Intelligence monitoring
  • Audit/Inspection Readiness
  • Pharmacovigilance training of PV and non-PV personnel
  • Pharmacovigilance agreements management

Our services include:

  • Establishment and maintenance of sponsor drug safety projects
  • Individual Case Safety Reports (ICSR) Management
  • Aggregate/Annual Safety Reports generation and reporting
  • Regulatory Intelligence monitoring

Want to work with us?