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PHARMACOVIGILANCE & MEDICAL

Pharmacovigilance & Medical

We offer one-off PV or Medical activities and ongoing portfolio support

Pharmacovigilance (PV) services:

  • Signal detection
  • Pharmacoepidemiology
  • PV systems development and implementation
  • Assessment and implementation of EU PV legislation
  • PSUR writing
  • Risk Management Plans
  • Report writing
  • Resource analysis and training
  • QPPV

PV inspection readiness:

  • Internal audit and process review
  • Educate staff to know what is to be expected
  • Rehearsal inspections
  • Inspection support and report response

PV inspection readiness:

  • Internal audit and process review
  • Educate staff to know what is to be expected
  • Rehearsal inspections
  • Inspection support and report response

Medical:

  • PV Physician
  • Medical sign-off of Regulatory documentation
  • Medical Affairs system set up to provide accurate information to healthcare professionals
  • Promotional material review