Pharmacovigilance Processes

Pharmacovigilance Processes are a cornerstone of Veram Bioclinical Solutions' services, ensuring the safety and efficacy of pharmaceutical products. Veram specializes in setting up and implementing robust pharmacovigilance systems, including the preparation and maintenance of the Pharmacovigilance System Master File (PSMF) and SOPs. The consultancy services offered extend to project management, guiding clients through regulatory requirements and best practices, ensuring compliance and patient safety.

Moreover, Veram Bioclinical Solutions provides comprehensive case management and Individual Case Safety Report (ICSR) processing services. From case intake and triaging to data entry and coding using standardized dictionaries like MedDRA, Veram ensures accurate and timely processing of adverse event reports. The team excels in writing narratives, conducting causality assessments, and performing labeling assessments, all critical components of pharmacovigilance. Veram also excels in quality reviews, medical reviews, and expedited reporting to regulatory authorities, ensuring that safety information is managed efficiently and in compliance with regulations.