Pharmacovigilance

With years of experience delivering regulatory support for our clients’ pharmacovigilance needs, our highly qualified team of safety professionals adheres to good pharmacovigilance practices with timely regulatory screening and reporting of adverse events and product complaints.

  • Complete initial screening for adverse events and product complaints
  • Prepare case narratives of Individual Case Safety Reports (ICSRs) from clinical trial and postmarketing sources
  • Provide detailed and systematic follow-up for all cases
  • Enter data into client’s safety database including:

    Evaluation of serious criteria

    Coding using MedDRA, WHO Drug, Company Drug Dictionary

    Expedited submission of ICSRs

  • Conduct medical review of cases
  • Conduct quality control activities
  • Conduct quality assurance activities
  • Detect, track, investigate, and evaluate signals and risk-benefit of product
  • Prepare regulatory safety reports (eg, PADERs, PSURs, PBRERs)
  • Conduct systematic review of medical literature
  • Provide metric reports on compliance, quality, and other key performance indicators
  • Write/revise standard operating procedures based on good pharmacovigilance practices
  • Provide support for Risk Management Plans (RMPS) and Risk Evaluation Mitigation Strategies (REMS)
  • Include comprehensive MedRa upgrades, in both English and Japanese, utilizing BKP Technologies’ BKP Codex Up-Versioning tool
  • Conduct audit inspection/readiness

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