our services

Pharmacovigilance and Drug Safety Expertise

At Tech Observer our Pharmacovigilance and Drug Safety group is dedicated solely to collecting, interpreting and reporting safety events on behalf of clients after their products are approved for marketing covering a broad spectrum of therapeutic areas. Our services span the life cycle of marketed medical products, including pharmaceuticals, biologics and medical devices.

Our Services include:
  • Individual Case Safety Reports (ICSRs)

  • Periodic Safety Update Reports (PSURs)

  • Annual Safety Reports (ASRs)

  • Summary Bridging Reports (SBRs)

  • Scientific Literature Surveillance

  • SAE Management and Reconciliation

  • Case Narrative Writing

  • Medical Coding

  • Safety Signal Detection

  • Epidemiology Consultation

  • Risk Management

  • Regulatory Consultation

Service Partners

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