Pharmacovigilance & safety services
Enhancing the safety profile of your product across all lifecycle phases
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1,400+
Global pharmacovigilance professionals -
100+
Countries -
99%
Compliance with regulatory reporting timelines
Seamless and transparent pharmacovigilance solutions
A comprehensive approach to collecting and assessing product safety information is critical for the success of clinical research and the maintenance of post-marketing product licenses. Our team of over 1,400 global pharmacovigilance professionals integrates all safety services into a streamlined, transparent delivery model, providing clear, easy-to-review outputs with a strong commitment to continuous quality improvement and operational efficiency.
Safety Reporting Group
ICON’s Safety Reporting Group ensures seamless regulatory compliance and efficient safety management, supported by advanced automation and global expertise.
Risk Management and Risk Evaluation & Mitigation Strategy (REMS) Solutions
Our integrated Risk Management team forms a comprehensive risk management solution tailored to the specific nature and needs of each of our clients. Our experts provide unparalleled support in managing risks throughout a product’s lifecycle.
Ensuring patient safety
From clinical development to post-marketing
Our safety experts use advanced technologies to monitor and define the safety profile of investigational and marketed products, supporting the early detection and management of safety risks to ensure patient safety.
Safety writing solutions
Our team of safety medical writers and scientists delivers compliant, cost-effective safety writing solutions, including aggregate reports, risk management planning, and document reviews, ensuring global regulatory compliance.
Global and local literature monitoring
With more than 15 years of specialised experience, ICON delivers expert literature searches across platforms such as PubMed and Embase. We provide routine weekly monitoring and focused reviews that support periodic reporting and signal management. Our team also conducts local surveillance in line with regional requirements and reviews outputs from the European Medicines Agency medical literature monitoring programme.
Case processing
Our comprehensive case processing capabilities include receipt, data entry, narrative writing, coding, quality control, medical review, query management, and safety submissions. We process hundreds of thousands of cases, demonstrating our commitment to high-quality, efficient safety management.
Robust project documentation and management
Successful project delivery relies on comprehensive project documentation, managed by skilled project personnel. At ICON, we maintain an extensive library of SOPs and procedures governing our pharmacovigilance services to ensure thorough staff training and high-quality standards.
Each client is assigned a functional lead who oversees all activities and ensures that deliverables consistently meet defined Key Performance Indicators (KPIs).
Post-marketing pharmacovigilance
ICON understands the importance of post-marketing pharmacovigilance. Our dedicated global team manages the safety of products post-launch in the market, covering end-to-end pharmacovigilance services in the post-marketing setting including drug and medical device case processing, signal detection, literature search and review, safety writing, EU QPPV, LPPV, PSMF management, risk management support and safety regulatory intelligence consulting.
Tailored pharmacovigilance solutions for biotech and small to mid-sized companies
At ICON, we recognise that biotech and small to mid-sized companies have distinct needs that set them apart from larger pharmaceutical firms. Our flexible, scalable, and cost-effective pharmacovigilance solutions are specifically designed to address these unique requirements. We ensure that you receive the same high level of personalised service, regardless of your organisation's size. Our pharmacovigilance solutions can be customised to meet your needs and evolve alongside your business.
Scalable and fully customisable models
Our operating models are fully flexible and can use ICON systems, sponsor systems or a combined approach. Services are available as consulting, standalone support, functional service provision, blended solutions or full service across all therapeutic areas.
ARGUS safety database
Using the Oracle ARGUS safety database, we configure a dedicated schema for each client, fully compliant with FDA 21 CFR Part 11 and supporting all standard regulatory and periodic reports. We also manage database migrations, including the transition of ongoing studies from other CROs and the seamless transfer of legacy databases.
Pharmacovigilance videos
Pharmacovigilance
Enhancing the safety profile of your product across all lifecycle phases.
ORCA Safety
Cloud-based, configurable business rules engine for ongoing monitoring of a product’s safety profile.
Signet
An intelligence tool for benefit–risk management and safety signal data visualisation to improve safety oversight.
Pharmacovigilance blogs and media contributions
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Media article: Beyond approval
In the October issue of PharmaTimes, Dr. Quintin van Wyk considers the importance of post-marketing pharmacovigilance, and explains how carefully applied automation and AI can strengthen adverse event reporting and causality assessment while keeping patient safety and regulatory compliance central.
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Blog: Post-marketing pharmacovigilance: ensuring product safety in the real world
Explore the critical role of post-marketing pharmacovigilance in protecting patients and maintaining compliance after your product enters the market.
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Blog: Advancing pharmacovigilance in a changing landscape: 2024 World Drug Safety Congress
The 2024 World Drug Safety Congress brought together pharmacovigilance experts to discuss the challenges and solutions in their profession.
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Blog: How AI could transform literature surveillance for pharmacovigilance
In pharmacovigilance AI could be used to detect adverse events sooner, offering benefits for patients and researchers.
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Blog: ISO 14155: increased emphasis on clinical data continues to trend for medical device regulations
Over the past several years, regulations for the medical device industry have continued to evolve placing more emphasis on clinical data and patient safety.
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Blog: Ensuring safety and compliance: the essentials of outsourcing pharmacovigilance
In this blog, we delve into the rationale behind outsourcing pharmacovigilance activities at the affiliate level and explore the essential requirements for appointing local persons for pharmacovigilance (LPPVs).
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