Pharmacovigilance

Svelte® 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