Risk management in healthcare comprises the clinical and administrative systems, processes, and reports employed to detect, monitor, assess, mitigate, and prevent risks. By employing risk management, healthcare organizations proactively and systematically safeguard patient safety as well as the organization’s assets, market share, accreditation, reimbursement levels, brand value, and community standing.
Pharmavigil team follow some fundamental components that belong in all healthcare risk management plans:
System establishment, PV-QMS & procedural development activities
Safety data collection, evaluation, understanding and prevention of ADRs/AEs
Development & submission of periodic safety writing reports
Global/Local Literature searching followed by classification
Queries (Call/Email) Receipt & Resolution Management
PharmaVigil is equipped with fully supported and regulatory compliant safety database solutions.
Quality and Compliance are highest priorities for us while handling drug safety and other activities.
Development & submission of PSMF/PSSF, PvMF & PSMF summary as part of module 1.8.2
RMP/REMS Risk identification followed by development of plan