QPPV: Qualified Person for Pharmacovigilance Services

Qualified Person for Pharmacovigilance Services

Yashfin provides end-to-end Qualified Person for Pharmacovigilance (QPPV) and Local Safety Responsible (LSR/LCPPV) services to support Marketing Authorisation Holders (MAHs) with compliant safety oversight, regulatory engagement, and continuous pharmacovigilance governance.
Our services are delivered in alignment with EU GVP and local authority requirements, ensuring inspection readiness and uninterrupted safety oversight.

Proven Experience:
30+ QPPVs appointed across multiple regions and regulatory jurisdictions.

QPPV appointed
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Appointment & Registration of EU QPPV and LCPPV
Support for formal appointment, documentation, and regulatory registration of EU QPPV and local QPPV/LCPPV.
EudraVigilance Registration & Maintenance
EudraVigilance user registration, role management, and routine updates in line with regulatory changes.
Daily ICSR Oversighte
Continuous monitoring of ICSR processing, including oversight of MHRA and other regulatory portals.
24/7 QPPV Retainer & Backup Support
Round-the-clock QPPV availability post-approval, supported by a dedicated, trained backup QPPV to ensure business continuity.
Signal Management & Safety Communication Oversight
QPPV involvement in signal management activities, safety communications, and regulatory interactions.
PSMF Maintenance & Updatess
Oversight, review, and approval of PSMF updates, ensuring ongoing compliance with EU GVP Module II.
Primary Point of Contact for NCAs
Acting as the official point of contact for National Competent Authorities (NCAs) during inspections, queries, and regulatory actions.
Local QPPV / LSR Legal Responsibility
Local QPPV or LSR assumes legal responsibility where required by national regulations.
Availability & Responsiveness
Availability during local business hours for MAH and NCA queries
Rapid response within 1 business day to regulatory or authority requests

A robust, inspection-ready QPPV framework that ensures continuous safety oversight, regulatory confidence, and full compliance across global markets.

Pharmacovigilance Services

Contact Us

  • B04-332, Business Center 03, RAKEZ Business Zone-FZ,
    Ras Al Khaimah, UAE
  • +971 55 895 5849
  • info@yashfin.net
    info@yashfinpharma.com

Our Brochures

Explore our Service Prospectus for a clear, easy-to-read overview of all services we offer.

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