Pharmacovigilance Services

Pharmacovigilance services from ProPharma Group

Pharmacovigilance Services You Can Rely on to Meet Your Safety and Compliance Needs

ProPharma Group processes thousands of adverse events each year on behalf of our pharmaceutical clients. We know the importance of complete and accurate case data, timely processing of regulatory reports and reliable processes to ensure that all is performed consistently and according to regulatory requirements.

We also know that pharmacovigilance is about more than documentation, coding, assessment, and signal detection… it is about the people we serve. At ProPharma Group, we share your concern for patient safety.

Our staff is dedicated to providing high quality services and we provide these services at a reasonable cost. We have the infrastructure in place to provide a compliant pharmacovigilance program you can trust and rely on. We focus on the safety of your patients and products so you can focus on other core business requirements. 

Pharmacovigilance Services:

  • 24/7 intake of adverse event cases by medical information specialists
  • Thorough, detailed case documentation in a secure, validated database
  • Timely and accurate regulatory reporting including MedWatch, CIOMS and all formats of Aggregate Reports
  • Medical literature searches to identify and process reportable cases
  • Intake and documentation of product complaints to aid your quality investigation
  • Access to case data for your internal reporting and trend analysis
  • A complete outsource of services or a resource to complement your current safety programs
  • Reduced costs by leveraging our staff and infrastructure
  • Distinctive quality and commitment in carrying out all processes.

 

Mike Burman is the Vice President of Global Medical Information at ProPharma Group. Mike has over 15 years’ experience working in Medical Information, a majority of which is based on the client side...View full bio