Postmarketing Safety Reporting
Ensuring patient safety is the most important component of a pharmacovigilance (PV) system. Therefore, all pharmaceutical and biotechnology companies are required to identify, collect, and process Individual Case Safety Reports (ICSRs) in a systematic and robust manner, and report to regulatory authorities in accordance with strict requirements and timelines.
Our PV specialists can partner with you to ensure your case processing requirements are fulfilled in compliance with regulatory legislation.
ICSR Expertise and Resources
We have deep experience in providing PV services, and specialize in ICSR processing and analyzing safety data including case intake, data entry, coding, medical review, follow up, quality control, and reconciliation.
We support clients by providing ICSR processing in a fully compliant and validated Argus safety database. Our system is secure and has appropriate backup, business continuity, and disaster recovery procedures in place. ProPharma Group’s processes and system are regularly audited and have a long history of compliance. In addition, we also have knowledge and experience with all major safety databases.
Expedited reporting is a fundamental activity in any PV system, and we understand compliance is business critical. Our PV experts monitor regulatory intelligence and stay informed of any changes in regulations and update core regulatory reporting procedures accordingly.
We also have specialized submissions teams who are qualified for electronic submissions to regulatory authorities.