IntuVigilance is the industry leader in the supply of EU as well as local QPPVs and Safety officers around the world.

Our global footprint includes North America/Canada, LATAM, EU/EEA, Middle East, Africa, Asia Pacific, Russia and CIS countries.

GVP Module 1 , UK Statutory Instrument 2012, along with myriad global regulations mandate a QPPV requirement in their territories. IntuVigilance maintains a pool of qualified and available QPPVs to support your needs with minimal on-boarding effort.

IntuVigilance has long since been the go-to organisation for local as well as global literature monitoring services. We offer a weekly centralised screening service with review and assessments completed by our QPPVs. This centralised offering is a highly cost effective and efficient solution whilst ensuring optimised safety surveillance activity.

Our team of highly skilled PV project managers ensure oversight and coordination of our clients’ PV system both centrally as well as locally.

Our project managers support the production and maintenance of a variety of PV documents: PSMFs, RMPs, PSURs, DSURS, Safety Summary reports, Safety Plans, etc.

Our global QPPV expertise includes preparing local PSSFs and PSURs where mandated by national legislation in worldwide territories. Our experience in such territories means that we have visibility of local requirements and specifications when producing such documents.

IntuVigilance provides full-service case management and expedited reporting services using our Argus SaaS safety database (R3 ready). We act as a global safety database holder for our customers. We also serve as the EU safety department for our customers in USA.

Our team of case processors manage the breadth and width of case management activities. In-built gateway connections within Argus allow for seamless expedited reporting to Regulatory Authorities as well as Agencies.

IntuVigilance hosts a robust suite of standard operating procedures, policies, working instructions and guidelines. Our QMS includes PV, QA, HR and IT system processes.

IntuVigilance is well equipped to support its customers with gap analysis and preparation and maintenance of client processes.

Our own procedures are utilised routinely within client contracts. Our QMS is regularly scrutinised and approved by auditors within the industry.

Partner and vendor audits are integral to a successful PV system. We provide trained experts to plan and conduct audits.

IntuVigilance regularly participates in audits and has developed robust procedures to support its clients with Inspection readiness activities.

The IntuVigilance PV universe is routinely audited to ensure a thorough awareness of PV system changes. Our project managers routinely conduct quarterly oversight meetings with our global partners to ensure PV system management.

Audits and Inspections in the PV universe is not a new concept with the MHRA PV Inspectorate being established in 2004, although, the focus on the PV quality System has increased in the introduction of the new GVP modules in 2012 making the risk-based approach now part of legislation.

IntuVigilance has a robust training schedule developed around its own QMS infrastructure. In addition, we support our clients with PV awareness training for sales force, as well as non-PV personnel within affiliate offices.

We provide ready-made or customisable training programmes through our PV Academy wherein our highly skilled faculty is always at hand to support mentorship and individual training needs.

Global country requirements form the basis of everything we do within drug safety and pharmacovigilance. Knowing the legislation in concerned countries, ensuring that you use the most current information and keeping on top of changing legislative requirements is a challenge across the Industry.

Based on decades of experience in this area, IntuVigilance has developed a regulatory collection system called ikyzen, that provides on-point country specific reporting rules that are readily available to our customers. For more information on ikyzen, please visit its website via this link