Pharmacovigilance:

  • Setup and maintenance of global safety databases

  • Receiving, processing and archiving adverse events and reaction information

  • Medical assessment of individual cases

  • Contribution to risk signal detection

  • Risk management strategy

  • Ensure compliance with local and international requirements

  • Safety reporting to Health Authorities and other parties

  • MedDRA coding and coding convention strategies

  • Medical support for SAE reconciliation

  • Preparation of written pharmacovigilance procedures (SOPs)

  • Preparation of SAE case narratives

  • Interim safety reports (on demand)

  • Annual safety reports

  • Periodic Safety Update Reports (PSUR)

  • QPPV services


For more information email us at info@pharexcelconsulting.com or contact us today.

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