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Post-marketing pharmacovigilance

Ensuring product safety in the real world

Pharmacovigilance of a drug or medical device does not end once the product reaches the market. The post-marketing phase presents a critical opportunity to understand how a broader patient population responds to a product. This phase introduces new challenges, and many drug and device developers turn to experienced partners for support. In this blog, we explore the importance of post-marketing pharmacovigilance and provide guidance on how to assess potential partners to meet your product’s ongoing safety and compliance needs.

The importance of post-marketing pharmacovigilance

Post-marketing pharmacovigilance detects, assesses and manages potential risks when a product is adopted by much larger population. When a product moves from the clinical trial environment to the real world, the increased number of variables introduces the risk of new or rare adverse events. Adverse effects must be documented and reported promptly to enable sponsors and regulators to respond to protect public health. Case processing is used to collate information about adverse events, assess their seriousness and causality, and report to regulators.

What to look for when choosing a post-marketing partner

Rigorous systems are necessary to manage the complexities of case processing while also balancing patient safety and commercial interests. Accuracy, consistency and compliance should be the driving factors when selecting a partner or system to manage case processing. But, at the same time efficiency and cost-effectiveness cannot be overlooked. When considering which partner or technology is best for your needs, ensure they are capable of the following:

  • Provide global coverage including multilingual support, as applicable to your current and future product launches
  • Understand the local regulatory requirements and have the infrastructure to support country-specific requirements
  • Support local PV activities including Local Person for PV where required, local literature review and local audits/inspections readiness and support
  • Compile comprehensive adverse event documentation and safety data management at a local and global level
  • Provide signal and risk management services, including implementation and tracking of risk minimisation measures (RMM) at country level
  • Provide medical writing services covering periodic safety update reports and Product Safety Master File
  • Meet regulatory compliance requirements to mitigate risks, avoid warnings and penalties
  • Integrate technology to enhance efficiency and provide real time access to the data via dashboards and cloud-based collaboration 

How ICON can help

ICON has a global team of 980+ pharmacovigilance professionals in Asia Pacific, the Americas and Europe. This 24/7 coverage guarantees seamless case processing to ensure patient safety and regulatory compliance worldwide. In the past five years we have successfully processed approximately 700,000 cases from post-marketing sources. We support pharmaceutical, biotech and medical device organisations of all sizes and across all therapeutic areas. We tailor our solutions to support our customers’ objectives and adapt as their business needs evolve. Using advanced technology, we optimise post-marketing case processing and pharmacovigilance to be highly efficient. 

ICON innovations include:

  • Automated data capture to reduce manual errors and accelerate processing with real-time updates
  • AI & machine learning to identify safety signals and enhance risk assessments
  • Real-time compliance monitoring to ensure regulatory adherence and minimise non-compliance risks
  • Cloud based solutions that enable seamless global collaboration with up to date data access
  • Integrated reporting tools that provided dynamic safety data visualisation for informed decision making
  • Enhanced data security to protect sensitive information with robust cyber security measures

Conclusion

Choosing a partner to manage your post-marketing pharmacovigilance requires assessing their scientific and data management expertise as well as their ability to work ways that work for you. Asking the right questions ensures your case processing system is thorough, accurate, and efficient, keeping your product safe and compliant.

Contact us to learn more about how we can support your post-marketing pharmacovigilance needs.

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