Pharmacovigilance at the country or in-country level.

Local QPPV and Local PV Persons

A critical part of the PV eco-system.

Local Qualified Persons for Pharmacovigilance (LQPPVs) are pivotal in maintaining a compliant, effective, and safe, country-specific pharmacovigilance system.

A safety role with many local variations.

The position of Local Qualified Person for Pharmacovigilance (LQPPV) is mandated by regulatory authorities to oversee the pharmacovigilance systems within a specific country or region and is based on regulatory frameworks like the European Union’s Directive 2001/83/EC and Regulation (EC) No 726/2004, as well as guidelines from the International Council for Harmonisation (ICH), particularly ICH E2E.

The LQPPV role is therefore critical for protecting public health, ensuring that medicinal products are safe and effective throughout their lifecycle by closely monitoring and managing the risks associated with them.

The title "Local Qualified Person Responsible for Pharmacovigilance" is commonly used in the European Union, but variations or equivalent roles exist in other legislations with similar responsibilities, such as:

  • Local Safety Officer (LSO).
  • Drug Safety Officer.
  • Pharmacovigilance Officer.
  • Local Contact Person Responsible for Pharmacovigilance (LCPPV).
  • National Contact Point (NCPPV/NCPV).

A preferred industry partner for Local QPPV and Local PV Person services.

iVigee is a world leader in local pharmacovigilance, combining global expertise, local knowledge, and the latest in Regulatory Intelligence technology. 

We have an extensive network of Local QPPVs or Local PV Persons in 120+ countries across the world and for each one we also nominate a deputy to ensure business continuity. We also have dedicated iViNetwork Managers to ensure a tailored solution for each client.

Our Local QPPVs and Local PV persons are already recruited and contracted, enabling us to deploy a complete local pharmacovigilance service within two months on average, during which we prepare all client-specific documentation and notify local regulatory agencies of the local QPPV or Local PV Person who will be in place.

Regulatory Intelligence collected from our Local QPPVs, and Local PV persons is validated and published in our iViReg knowledge management center, providing a comprehensive and up to date system that provides real, actionable insights into local level legislative change and its potential impacts. 

And our Local Literature Monitoring service searches for case reports and relevant safety information according to the agreed journal review selectin and strategy.

iVigee provides a dedicated, efficient, and rigorous approach to your local pharmacovigilance needs. Our dedicated team, with its in-depth training and years of experience, offers unrivalled support and advice for changing regulations, making us a preferred partner in the industry.

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