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Quality Person for Pharmacovigilance (QPPV) is responsible for the management of pharmacovigilance and quality activities on behalf of a pharmaceutical organization. QPPV is a point of contact for regulatory authorities with respect to the benefit-risk data of a product and must ensure that MAHs have an adequate pharmacovigilance system in place that is compliant with the regulatory requirements of the region. QPPV oversees various pharmacovigilance activities that include quality audits, signal management and preparation of audits and training among others. Global authorities have mandated the appointment of a QPPV for countries in which medical products are to be authorized in where each region has its own set of requirements for a QPPV- from their qualification to their citizenship/residential status.

DDReg has a team of QPPVs across the globe to provide seamless support in establishing a QPPV and hence a sound pharmacovigilance system. Our QPPV services offer expertise in maintaining safety compliance with legal and regulatory requirements and ensure that all pharmacovigilance documents are complete and correct, and oversee concerns about the safety of medicines.

DDReg QPPV Pharmacovigilance Services include:

  • Development of PSMF
  • Review of SDEA agreements, agreements with commercial partners
  • Registration for Eudravigilance as QPPV /Deputy QPPV,
  • Notification to competent authority on
  • ➔ QPPV & PSMF change
  • ➔ Amendment to QMS for PV and
  • ➔ Development of PV SOPs
  • Retainer services for QPPV and Deputy
  • Monthly reconciliation
  • Signal Detection
  • ➔ Medical review of Signal detection data prior to Qrtly meeting
  • ➔ Signal Surveillance Meetings (Quarterly)
  • Monthly Communication report/provision of compliance metrics
  • Generation of frequency tabulations & necessary data for signal management
  • PV Quality Management System Oversight