• IntuVigilance is a leading provider of EU and local Qualified Person Responsible for Pharmacovigilance (QPPV) services and Safety Officers worldwide.
• Our global presence spans North America, Canada, Latin America, the EU/EEA, the Middle East, Africa, Asia Pacific, Russia, and the CIS countries.
• We expertly manage all pharmacovigilance-related inquiries from health authorities, ensuring compliance and safety in drug monitoring.
• We specialize in creating comprehensive pharmacovigilance systems tailored to meet the specific needs of each client.
• IntuVigilance has a readily accessible pool of qualified QPPVs, facilitating seamless integration with minimal onboarding requirements.
• Our robust monitoring processes involve the systematic collection, analysis, and sharing of regulatory updates at global, regional, and local levels.
• Our range of services generally includes the appointment of a QPPV to oversee the pharmacovigilance system, the maintenance of the Pharmacovigilance System Master File (PSMF), management of safety data, and coordination with local pharmacovigilance representatives (LPPVs) to ensure compliance with country-specific regulations.

IntuVigilance has established itself as the premier organization for both local and international literature monitoring services. Our comprehensive weekly centralized screening service is meticulously conducted by our Qualified Person Responsible for Pharmacovigilance (QPPVs), who carry out thorough reviews and assessments.

This centralized approach not only enhances the efficiency of safety surveillance activities but also represents a highly cost-effective solution for our clients. By leveraging our expertise, we ensure that safety monitoring is optimized, allowing organizations to focus on their core operations while we manage the complexities of literature monitoring with precision and reliability.

Our team of expert project managers in pharmacovigilance (PV) systems provides comprehensive oversight and coordination for our clients, ensuring effective management both at the central and local levels.

These professionals are instrumental in the development and maintenance of a wide range of essential PV documentation, including Product Safety Management Files (PSMFs), Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Safety Summary Reports, and Safety Plans, among others.

With a robust global expertise in Qualified Person for Pharmacovigilance (QPPV), we are adept at preparing local Product Safety Summary Files (PSSFs) and PSURs in compliance with national regulations across various jurisdictions. Our extensive experience in these regions equips us with a thorough understanding of local requirements and specifications, ensuring that all documentation is not only accurate but also aligned with the specific legal frameworks governing each territory.

IntuVigilance offers comprehensive case management and rapid reporting services through our Argus SaaS safety database, which is R3 ready. We serve as a global safety database custodian for our clients, leveraging a diverse team located across Latin America, the United Kingdom, and India to efficiently manage a wide array of case management tasks.

Our skilled case processors are adept at overseeing all aspects of case management, ensuring that every detail is meticulously handled. The Argus platform features integrated gateway connections that facilitate smooth and expedited reporting to regulatory authorities and agencies, enhancing our clients’ compliance and operational efficiency.

IntuVigilance offers a comprehensive array of standard operating procedures, policies, working instructions, and guidelines that form the backbone of our Quality Management System (QMS). This system encompasses critical processes across pharmacovigilance (PV), quality assurance (QA), human resources (HR), and information technology (IT), ensuring a cohesive operational framework.

We are adept at assisting our clients with gap analyses and the development and upkeep of their processes, thereby enhancing their operational efficiency. Our established procedures are consistently integrated into client contracts, reflecting our commitment to quality and compliance.

Furthermore, our QMS undergoes regular evaluations and receives approval from industry auditors, underscoring our dedication to maintaining high standards and continuous improvement in our services.

Partner and vendor audits play a crucial role in the effectiveness of a pharmacovigilance (PV) system. Our team comprises trained professionals who are adept at planning and executing these audits to ensure compliance and operational excellence.

IntuVigilance actively engages in audit processes and has established comprehensive procedures to assist clients in preparing for inspections. To maintain a high level of awareness regarding changes within the PV system, we conduct regular audits of the IntuVigilance PV universe. Our project managers hold quarterly oversight meetings with our global partners, ensuring that the management of the PV system remains effective and aligned with best practices.

Although audits and inspections in the PV domain have been in place since the establishment of the MHRA PV Inspectorate in 2004, the emphasis on the quality of the PV system has intensified following the introduction of new Good Vigilance Practice (GVP) modules in 2012. This shift has integrated a risk-based approach into the legislative framework, underscoring the importance of maintaining rigorous standards in pharmacovigilance.

IntuVigilance has established a comprehensive training program that is intricately aligned with its Quality Management System (QMS) framework. This program not only enhances internal capabilities but also extends to our clients, offering pharmacovigilance (PV) awareness training tailored for sales teams and non-PV staff in affiliate offices.

Through our PV Academy, we deliver both pre-designed and customizable training modules, ensuring that our highly experienced faculty is readily available to provide mentorship and address the specific training requirements of individuals. This approach guarantees that all participants receive the support they need to excel in their roles and maintain compliance with industry standards.

The foundation of our operations in drug safety and pharmacovigilance is built upon the global requirements set forth by various countries. It is essential to be well-versed in the relevant legislation of each jurisdiction, utilize the most up-to-date information, and stay informed about the evolving regulatory landscape, which presents a significant challenge for the industry as a whole.

Drawing from decades of expertise in this field, IntuVigilance has created a comprehensive regulatory collection system known as ikyzen. This innovative platform offers precise, country-specific reporting guidelines that are easily accessible to our clients, ensuring they remain compliant with local regulations.

For further details about ikyzen, we invite you to explore its dedicated website through the provided link.