Postmarketing PV Services
A Leading Provider of Timely, Accurate Reporting and the Early Detection of Safety Issues
At ProPharma Group, we believe a compliant and comprehensive pharmacovigilance program is fundamental to the long-term success of your product. ProPharma Group partners with our clients to meet their postmarketing surveillance requirements which can include outsourcing components of PV to supplement your existing team, or a complete outsource of your PV function.
ProPharma Group is an industry leader in providing a comprehensive suite of global pharmacovigilance services, including case processing, aggregate reporting, literature screening, European and local Qualified Persons, and signal detection. Our staff is dedicated to providing consistent support, utilizing established processes to ensure regulatory compliance. Our expert staff and robust infrastructure ensures a compliant program you can trust.
- 24/7 intake of adverse event cases by our medical information contact centers
- Thorough, detailed case processing in a secure, validated Argus database
- Timely and accurate regulatory reporting of individual case safety reports, including MedWatch and CIOMS
- Aggregate reporting, including PADER, PBRER, and PSUR formats
- Signal detection and analysis by medical staff
- Screening of global medical literature to identify and process reportable adverse events
- QPPV and LPPV services to meet European requirements
- Online access to case data via our web portal, Case Explorer®, for monitoring case management and safety data
- A complete outsource of services or resources to complement your current PV department
- Reduced costs by leveraging our staff and infrastructure