Pharmacovigilance (PV)

PV System set-up

  • Creation and maintenance of local PV Master documents
  • Provision of staff trainings
  • Preparation for audits and inspections
  • Development of KPIs
  • Management and implementation of CAPAs

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Scientific Literature Screening

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Local PV Services

  • LQPPV provision
  • Local Regulatory Review and Validation
  • Medical and pharmaceutical information provision

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Regulatory Intelligence

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Document Preparation And Management

  • Standard Operating Procedure (SOP)
  • Pharmacovigilance System Master File (PSMF)
  • Periodic Safety Update Report (PSUR)
  • Risk Management Plan (RMP)

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Safety Reporting (Pre And Post registration)

  • ICSRs preparation, submission and follow-up
  • Safety database for reporting and archiving
  • Safety information reconciliation
  • Development of Safety Plans in clinical trials

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