October 07, 2025

Pharmacovigilance (PV) has become increasingly complex in recent years. With expanding regulatory requirements, competitive market pressures, and rising costs of drug development, companies are under pressure to maintain compliance while optimizing operations. In the European Union (EU), there are 16 Good Pharmacovigilance Practice (GVP) modules that define the requirements for pharmacovigilance systems across all authorized products. Each module represents a critical process, making PV an extensive and resource-intensive function for any marketing authorization holder (MAH).

To meet these demands, many organizations are now embracing end-to-end pharmacovigilance outsourcing models — transferring all legislated requirements to trusted outsourcing partners who can manage safety activities at both global and local levels.

Benefits of End-to-End Pharmacovigilance Outsourcing

When structured correctly, full-service PV outsourcing provides a wide range of operational and strategic benefits:

  • Access to expertise: Strengthens internal PV teams with experienced global and local pharmacovigilance specialists.
  • Cost reduction: Decreases operational expenses while maintaining — or even improving — reporting quality.
  • Clear oversight: Advanced dashboards and KPI monitoring enable transparent tracking of outsourced tasks.
  • Strategic focus: Allows PV leaders to concentrate on high-value activities such as risk management and patient safety strategies.
  • Market expansion: Facilitates smoother entry into new regions through structured and compliant global PV processes.
  • Reduced local risks: Avoids regulatory delays by ensuring compliance with country-specific PV requirements.

Navigating Regulatory Requirements

PV requirements are not uniform across regions. Companies must understand both global GVP standards and local market obligations.

  • In the EU, GVP requirements apply to MAHs, national competent authorities (NCAs), and the European Medicines Agency (EMA). However, each member state may interpret and enforce requirements differently.
  • For example, 17 EU countries require a local PV presence after marketing authorization is granted — even if the product is not marketed in that country.
  • Every MAH must maintain a Pharmacovigilance System Master File (PSMF), in line with GVP Module II.
  • A Qualified Person for Pharmacovigilance (QPPV) and a backup QPPV are mandatory. Their responsibilities include PSMF management and oversight of Safety Data Exchange Agreements (SDEAs).

Alongside pharmacovigilance, companies must also manage medical information inquiries. Local-language support from trained pharmacists or qualified professionals ensures patients and healthcare providers receive accurate responses, and any reported adverse events are captured.

Commonly Outsourced PV Services

Outsourcing partners often support companies with core PV activities, including:

  • Case processing / Individual Case Safety Reports (ICSRs)
  • Aggregate report writing (e.g., Periodic Safety Update Reports – PSURs)
  • Global literature screening
  • Signal detection and benefit-risk management
  • PSMF preparation and updates
  • Safety data reporting to authorities
  • Risk Management Plan (RMP) updates

In best practice models, outsourcing partners work cross-functionally with regulatory and quality teams to deliver a fully integrated PV solution.

 

Must-Haves for Full-Service PV Outsourcing

For companies to maximize the benefits of PV outsourcing, the chosen partner must operate under a well-structured framework that ensures compliance, quality, and transparency. Key considerations include:

  1. Trusted safety database platforms for case management and reporting.
  2. Clear PV system governance, including defined hierarchy, communication channels, and a single point of contact.
  3. Local PV expertise, ensuring compliance with country-specific requirements.
  4. Business continuity planning, with robust backup systems to prevent service interruption.
  5. Strong KPI-based quality controls, covering areas such as case processing accuracy, data entry quality, medical judgment, and submission timelines.
  6. Value-added services such as:
    1. Third-party PV audits
    2. Corrective and preventive action (CAPA) management
    3. Mock inspections to ensure inspection readiness

Role of Technology in PV Outsourcing

Technology and automation are becoming central to modern pharmacovigilance. A capable outsourcing partner should offer:

  • Automation tools for case intake and signal detection.
  • AI-driven solutions to reduce manual workload, accelerate processing, and enhance accuracy.
  • Data-driven dashboards for real-time oversight and compliance monitoring.

By leveraging these tools, companies can reduce costs, minimize errors, and achieve faster reporting timelines.

 Conclusion: Reducing the PV Burden Through Outsourcing

While the ultimate accountability for pharmacovigilance always remains with the marketing authorization holder, outsourcing to a trusted partner can dramatically reduce the operational burden.

By transferring end-to-end PV processes — from case management to PSMF oversight — companies can:

  • Achieve cost savings and efficiency gains
  • Ensure global and local compliance
  • Free internal teams to focus on strategic safety initiatives and innovation

At Maven Regulatory Solutions, we deliver comprehensive end-to-end pharmacovigilance outsourcing services tailored to the needs of pharma, biotech, and medical device companies. Our global expertise, local presence, and technology-driven solutions ensure regulatory compliance while enabling clients to focus on growth and innovation.