Through our virtual network of pharmacovigilance experts we have access to extensive skills and experience in the processing of adverse events that originate from:
- Pre- and post-authorization studies
- Spontaneous reports
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.
In addition, our experts are also skilled in the worldwide requirements for reporting:
- Individual Case Safety Reports (ICSRs)
- Suspected Unexpected Serious Adverse Reactions (SUSARs)
- Periodic Safety Update Reports (PSURs)
- Development Safety Update Reports (DSURs)
- 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.