SvelteĀ® scientific offers expert support to Pharmacovigilance departments, particularly in relation to the following areas:

  • Processing adverse events (AEs)
  • Coding AEs
  • Coordination of actions related to Pharmacovigilance
  • Preparation and up-dating of reports on Pharmacovigilance, including the Periodic Safety Update Report (PSUR), Development Safety Update Report (DSUR) and Periodic Benefit Risk Evaluation Report (PBRER),
  • Preparation of Clinical Overviews and Clinical Summaries
  • Literature research
  • Developing and up-dating the Risk Management Plan
  • Safety-related input in the planning and performance of clinical studies
  • Quality assurance in Pharmacovigilance