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Pharmacovigilance Services

Comprehensive Support for Drug Safety

At Saint Security, our commitment to pharmacovigilance encompasses a broad spectrum of services for both products in development and those already on the market. Our dedicated team provides an extensive range of activities, ensuring the highest standards of drug safety and regulatory compliance.

Key Activities in Our Pharmacovigilance Portfolio:

  • Country Safety Contact: We offer dedicated local safety contacts across various countries to ensure compliance with regional pharmacovigilance regulations.
  • Local Literature Search: Our team conducts thorough searches of local medical and scientific literature to identify and evaluate potential safety information.
  • Local Qualified Person for Pharmacovigilance (QPPV) and Deputy Local QPPV: We provide expert QPPV services, including a deputy QPPV, to oversee and manage all pharmacovigilance aspects within the European Union.
  • Study Safety Plans: Development and implementation of robust safety plans for clinical studies, ensuring patient safety and regulatory adherence.
  • Medical Review and Processing of Adverse Events (AEs) and Serious Adverse Events (SAEs): Our experts meticulously review and process AE and SAE reports, providing critical analysis and insights.
  • Development and Implementation of Risk Management Plans: We assist in creating and implementing proactive plans to identify, assess, and minimize drug risks.
  • Setup and Execution of Post-Authorization Safety Studies (PASS): Our services include the design and execution of studies to assess the safety of drugs after market authorization.
  • 24/7 Safety Telephone Service: We offer around-the-clock telephone support for safety inquiries, ensuring continuous access to expert guidance.

At Saint Security, our approach to pharmacovigilance is meticulous, proactive, and in strict adherence to regulatory standards. We are dedicated to ensuring the safety of pharmaceutical products, contributing to the well-being of patients, and supporting our clients in navigating the complexities of drug safety monitoring.