Pharmacovigilance & Safety science 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 1,000 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.
- Assigned functional lead for clear communication routes and accountability
- Industry-leading pharmacovigilance regulatory intelligence for over 100 countries
- Over 99% compliance with regulatory reporting timelines
- Global reach and round-the-clock coverage for clinical trials, post-marketing and medical device submissions
- Cost effective high-quality case processing model
- ORCA Safety
- PV Affiliate Solution
- Global medical information call centre services
- Pharmacovigilance specialised services including safety surveillance, aggregate safety report generation, risk management solutions, literature surveillance
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 blogs and media contributions
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Blog: Safety reporting in LATAM is changing, are you ready?
LATAM is evolving to electronic safety reporting and it is essential to be prepared for it.
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Blog: The impact of COVID-19 on pharmacovigilance
COVID-19 is affecting how clinical trials are managed, in terms of patient recruitment, patient care, data collection, analysis and safety reporting.
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Media article: The Significant Role of a Robust Regulatory Intelligence Process in Global Safety Submissions
Pharmacovigilance insights on the efforts towards the international standardisation of electronic transmission of drug safety information to achieve a unified objective of patient safety.
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Blog: Limiting potential carcinogenic risk in drug development with reliable predictions
ICON's Mgr, Nonclinical Safety Assessment, Drug Development Consulting discusses the challenges & opportunities of in silico analysis in toxicology.
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Blog: EMA ISO IDMP - The path forward
The EMA is implementing the standards developed by the ISO for the IDMP.
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Blog: The final countdown to the overhaul of Pharmacovigilance in the EEA
In October, the European Medicines Agency (EMA) released their much anticipated Go-Live plan following input from all of the National Competent Authorities in the European Economic Area (EEA).
