Pharmacovigilance services
Ensuring Drug Safety
Pharmacovigilance:
Qualified Person of Pharmacovigilance (QPPV) Outsourcing
Pharmacovigilance services provide skilled QPPV outsourcing to oversee compliance, ensuring the effective management of safety responsibilities.
Pharmacovigilance System Master File (PSMF)
Comprehensive PSMF preparation by pharmacovigilance companies organizes critical safety data, supporting regulatory and operational excellence.
Risk Management Plan (RMP)
Expertly crafted RMPs within the pharmacovigilance scope mitigate risks by identifying, assessing, and minimizing potential drug safety issues.
Individual Case Safety Report (ICSR)
Detailed ICSRs prepared by pharmacovigilance services facilitate the accurate documentation and submission of adverse event reports.
Periodic Benefit Risk Evaluation Report (PBRER)
Pharmacovigilance services compile thorough PBRERs, analyzing drug safety and efficacy over time to maintain regulatory compliance.
Addendum to Clinical Overview (ACO)
Tailored ACOs developed by pharmacovigilance companies enhance the presentation of critical safety and efficacy data in regulatory submissions.
Local Display
Localized safety data handling ensures compliance with regional regulations, strengthening pharmacovigilance in Egypt and other regions.
Pharmacovigilance Training for Different Levels
Pharmacovigilance services deliver specialized training programs, equipping teams with knowledge tailored to varying levels of expertise.
Local & Global Literature Screening (Weekly, Monthly & As Requested)
Regular local and global literature screening identifies safety signals, expanding the pharmacovigilance scope to include emerging data trends.
Standers Operations Procedures (SOPs) Development
Developing SOPs through pharmacovigilance services standardizes safety processes, promoting consistent and efficient safety practices.
Performing Qualification Audits
Thorough qualification audits by pharmacovigilance companies verify compliance and optimize safety management systems.