Overview

Patients and health care professionals expect medicines to be safe and effective, yet only very few medicinal products are without any known risks. The majority of medicines have side effects and the safety activities should be a continuous process during the lifecycle of a medicinal product (Clinical studies and post marketing experience).

At HeaDS, our trained professionals have a comprehensive technical and practical knowledge of pharmacovigilance regulations and collaborate closely with Medical Affairs, Clinical Operations, Data Management and Regulatory departments to ensure:

  • Full safety service requirements, including safety database
  • Compliance with the relevant legislations
  • A meaningful and consistent safety database

Services

Services

Eudravigilance

  • Registering Sponsors and MAHs with Eudravigilance
  • Electronic reporting of SUSARs & SARs to Eudravigilance
  • XEVMPD entry and maintenance

Writing

  • Preparation of safety texts for study protocols and Clinical Study Reports
  • Safety Management Plan
  • Aggregate report preparation (Development Safety Update Reports- DSURs, 6-Month SUSAR Reports, Periodic Safety Update Reports – PSURs)
  • SAE forms and SAE forms’ completion guidelines
  • Pharmacovigilance SOPs
  • SAE Narratives

Reporting

  • SAE triaging
  • SAE reconciliation
  • Aggregate reports; distribution & submission
  • Medical literature search

Training

  • Pharmacovigilance training
  • SAE reporting
  • AE coding and grading

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