Case Management

Case Processing

Through our virtual network of pharmacovigilance experts we have access to extensive skills and experience in the processing of adverse events that originate from:

  1. Pre- and post-authorization studies
  2. Spontaneous reports
  3. Literature

These skills cover: scientific knowledge; data entry; data QC; medical review; reporting; follow up; case closure and case file archiving.  We are able to work using your PV systems or our in-house facility.

Case Reporting

In addition, our experts are also skilled in the worldwide requirements for reporting:

  1. Individual Case Safety Reports (ICSRs)
  2. Suspected Unexpected Serious Adverse Reactions (SUSARs)
  3. Periodic Safety Update Reports (PSURs)
  4. Development Safety Update Reports (DSURs)
  5. Annual Safety Reports (ASRs)

This ensures that all reportable cases and cummulative reports are transmitted to the appropriate regulatory authority in compliance with the legislation. As a result virtualpv is able to offer you quality support for all your reporting requirements.