Facebook
  1. Home
  2. Solutions
  3. Clinical & Scientific Operations
  4. Pharmacovigilance
  5. Post-marketing pharmacovigilance

Post-marketing pharmacovigilance

Safeguarding patients beyond approval

The safety of drugs and medical devices does not end with approval. Instead, approval marks the beginning of a critical new phase of post-marketing. Once products enter the market, they are used by broad patient populations under real-world conditions, which can give rise to new safety concerns.

  • 1,000+

    global PV professionals

  • 24/7

    support

  • 700,000+

    cases

ICON understands the importance of post-marketing pharmacovigilance. Our dedicated team of global experts specialises in post-marketing and medical device case processing, delivering thorough, accurate and timely case management to ensure patient safety and regulatory compliance worldwide.

A commitment to excellence

Our rigorous systems ensure accuracy, consistency and compliance, providing cost-effective, high-quality pharmacovigilance solutions. We focus on:

Comprehensive adverse event documentation

Accurate MedDRA and WHO Drug coding

Regulatory compliance to mitigate risks

Technology integration for enhanced efficiency and real-time reporting

Driving efficiency with innovation

ICON leverages advanced technology to optimise post-marketing case processing and pharmacovigilance. 

Our key innovations include:

  • Automated data capture to reduce manual errors
  • AI and machine learning for signal detection and risk assessment
  • Real-time compliance monitoring
  • Cloud-based solutions for global collaboration
  • Integrated reporting tools for dynamic safety data visualisation
  • Enhanced data security

End-to-end pharmacovigilance solutions

 

Collection and documentation of adverse events

Our case processing begins with the systematic collection of adverse event reports from a variety of sources, including patients, healthcare professionals, literature, and post-approval studies.

Triage and case prioritisation

Adverse event reports are triaged based on their seriousness, prioritising cases that may pose significant risks to patient safety, such as life-threatening events.

Assessment and causality evaluation

We conduct thorough evaluations to ensure each report is complete and accurate. Our assessment focuses on causality and consistency with known safety profiles.

Data entry and medical coding

Information is entered into the pharmacovigilance database using standardised medical coding systems (MedDRA and WHO Drug Dictionary) to ensure consistent categorisation of adverse events and drug names. 

Determining seriousness and regulatory reportability

Each case is assessed as serious or non-serious according to established criteria, ensuring timely reporting to regulatory authorities to mitigate potential risks.

Support on your terms

ICON’s post-marketing pharmacovigilance team supports pharmaceutical, biotech and medical device organisations of all sizes and across all therapeutic areas. Services can be delivered as consulting, standalone, FSP, blended or full service and across all therapeutic areas.

Partner with ICON to ensure accuracy, compliance and efficiency in your post-marketing safety processes.

Contact us
In this section

Connect with us