Regulatory Requirement for QPPV & Pharmacovigilance Compliance
Under EU Directive 2001/83/EC, every Marketing Authorisation Holder (MAH) is required to appoint a Qualified Person for Pharmacovigilance (QPPV) responsible for maintaining a compliant pharmacovigilance system.
Failure to meet this requirement can result in inspection findings, regulatory action, or product suspension, especially if patient safety monitoring and reporting are not properly managed.
Pharmacovigilance systems are expected to follow EU Good Pharmacovigilance Practices (GVP Module I), ICH E2E guidelines, and country-specific regulations to ensure continuous safety oversight and compliance.
Request a QPPV ConsultationQPPV & Local Pharmacovigilance Services
Global oversight. Local compliance
Qualified Person for Pharmacovigilance (QPPV) Services
Qualified Person for Pharmacovigilance (QPPV) Services
QPPV services ensure pharmacovigilance systems remain compliant, audit-ready, and aligned with regulatory requirements, with clear accountability for patient safety.
- QPPV Designation :Formal appointment with responsibility for patient safety oversight and regulatory compliance
- PSMF Management: Maintenance of the Pharmacovigilance System Master File (PSMF) in line with regulatory expectations
- PV Agreements & SOPs: Authoring and review of SDEAs, PVAs, and SOPs aligned with GVP
- PV Gap Analysis: Identification of compliance gaps across pharmacovigilance systems and processes
- Safety Oversight: Continuous monitoring of benefit-risk profiles across marketed products
- Regulatory Interaction: Support for authority communication and inspection readiness
- Crisis & Signal Management: Structured escalation and coordination with authorities for emerging safety issues
In all activities, patient safety and data integrity are paramount, and we leverage global regulatory intelligence to adapt to evolving requirements
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Local Pharmacovigilance (LPPV / LSO) Services
Local Pharmacovigilance (LPPV / LSO) Services
LPPV services ensure compliance with country-specific pharmacovigilance requirements, supporting local regulatory obligations and continuous patient safety oversight across EU markets.
- Local PV Contact (LPPV/LSO):Designated contact for national regulatory authorities across EU member states
- Regulatory Liaison: Coordination and communication with local competent authorities
- PV Agreements & SOPs: Authoring and review of SDEAs, PVAs, and SOPs aligned with GVP
- PV Gap Analysis: Identification of compliance gaps across pharmacovigilance systems and processes
- Adverse Event Management: Local intake, reporting, and coordination of safety cases
- Local Compliance Oversight: Alignment with country-specific PV requirements, including PSMF/PSUR obligations
- Inspection Support: Preparation and support for national authority inspections
- Regulatory Intelligence Monitoring of local guideline updates and reporting requirements
In all activities, patient safety and data integrity are paramount, and we leverage global regulatory intelligence to adapt to evolving requirements
Talk to LPPV ExpertKey Features
Network of EU-qualified pharmacovigilance professionals with extensive experience
Multi-country coverage through strategic partnerships
Dedicated or shared QPPV/LPPV models tailored to client needs
Seamless handover and business continuity planning
Inspection readiness and mock inspection support
In-house AI-driven regulatory intelligence supporting compliance monitoring
A Process You Can Rely On
Clarity in every step. Confidence in every outcome.
Sciom follows a structured onboarding approach to integrate QPPV oversight within the pharmacovigilance system, ensuring compliance, continuity, and inspection readiness.
PV System Assessment
Evaluation of existing pharmacovigilance processes, SOPs, safety database, and governance against EU GVP requirements
Compliance Gap Analysis
Identification of gaps across case processing, reporting timelines, PSMF structure, and PV oversight
QPPV Appointment & Notification
Formal QPPV designation and preparation of documentation for regulatory authority notification
PSMF Alignment
Update and alignment of the Pharmacovigilance System Master File to reflect system structure and responsibilities
PV Agreements & SOPs
Review or development of SDEAs, PV agreements, and SOPs aligned with regulatory requirements
Operational Integration
Integration of QPPV oversight into safety activities, including case management, signal detection, and reporting
Ongoing Oversight
Continuous compliance monitoring, safety governance, and inspection readiness
Our QPPV/LPPV service Coverage
EU
UK
US
Brazil
Mexico
Canada
Middle East
European Union
Regulatory requirements and pharmacovigilance services across EU region.
United Kingdom
UK-specific regulatory and compliance services.
United States
US pharmacovigilance and regulatory landscape.
Brazil
Brazil-specific healthcare regulations and PV services.
Mexico
Regulatory requirements in Mexico.
Canada
Canada healthcare compliance and PV services.
Middle East
Middle East regulatory standards and pharmacovigilance practices.
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QPPV & LPPV FAQs
Frequently Asked Questions
Can Sciom act as a QPPV for a non-EU pharmaceutical company?
Yes. Non-EU Marketing Authorisation Holders marketing products within the EU must appoint an EU-based QPPV. Sciom can provide compliant QPPV services and coordinate with your global pharmacovigilance system.
How do you ensure 24/7 QPPV availability as required by EU regulations?
Sciom operates a structured pharmacovigilance governance model with defined escalation procedures, deputy coverage, and documented business continuity plans. This ensures continuous availability of QPPV oversight for regulatory authority communication, safety signal escalation, and urgent pharmacovigilance decisions.
How do you manage local pharmacovigilance requirements across different EU countries?
Sciom maintains a network of Local Pharmacovigilance Contacts (LPPVs/LSOs) and regulatory partners across EU territories. These professionals manage communication with national competent authorities, oversee local reporting obligations, and ensure compliance with country-specific pharmacovigilance requirements and language obligations.
Who retains ownership of the Pharmacovigilance System Master File (PSMF)?
The Marketing Authorisation Holder (MAH) remains legally responsible for the pharmacovigilance system. Sciom supports PSMF maintenance, oversight, and regulatory readiness, ensuring the document accurately reflects operational pharmacovigilance activities and QPPV responsibilities.
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