Pharmacovigilance

Drug Safety/Pharmacovigilance services

In recent years there has been an increased focus on Drug Safety and Pharmacovigilance, and this combined with more complicated regulatory requirements, means that a complete and wide-ranging knowledge is required to maintain compliance with world wide Drug Safety/Pharmacovigilance obligations.

Billev Pharma Aps offers established full Drug Safety/Pharmacovigilance services for pharmaceuticals and nutritional supplements. Billev Pharma Aps provides you with procedures and processes that are in compliance with EMA regulations/guidelines for safety and risk management. Each client is offered a tailored solution to meet their specific requirements, including both global and local projects.

We provide expertise in the following areas:

• EEA Qualified Person for Pharmacovigilance (QP Pv), 24 hour, 7 day availability
  
  
• Local Qualified Person/Representatives where required
  
  
• Comprehensive AE and SAE management (tracking, narratives, coding, follow-up)
  
  
• Electronic Reporting to EMA and European Competent Authorities
  
  
• Weekly Literature Searches
  
  
• Line Listing and Signal Detection
  
  
• Risk Management
  
  
• Periodic Safety Update Report (PSUR), creation, review and submission
  
  
• Client-tailored SOPs and working practices
  
  
• Creation of Company Core Safety Information