Sciensus’ pharmacovigilance services
Since 1992, Sciensus has ensured that taking care of our patients and improving their lives is at the heart of everything we do across the European healthcare ecosystem. Pharmacovigilance (PV) is the science of detection, assessment, understanding and prevention of side effects of medicine to make sure they are safe and compliant. With decades of experience in this field, we work to make sure our patients receive the best possible care and advice and pharmaceutical companies deeply understand the needs of those in our care. As one of the world’s premier pharmacovigilance service providers, we believe that the safety of patients is paramount.
Our years of expertise in pharmacovigilance have resulted in comprehensive patient monitoring and reporting, especially when it comes to direct feedback. This includes the whole product lifecycle from clinical trials to post-marketing surveillance. That’s why we have a trusted case management system in place which is designed to ensure consistent, compliant handling of safety data from initial capture through to regulatory submission.
Comprehensive pharmacovigilance solutions
Sciensus supports pharmaceutical and biotech partners across all phases of clinical development, from first-in-human to pivotal and post-authorisation studies.
Our services include:
- ICSR/SAE/SUSAR case management
- Development Safety Update Reports (DSURs)
- Global and local regulatory compliance (MHRA, EMA, FDA)
- Early signal detection and benefit-risk evaluation
- Seamless integration with CROs and clinical trial teams
Clinical trial pharmacovigilance
Sciensus supports pharmaceutical and biotech partners across all phases of clinical development, from first-in-human to pivotal and post-authorisation studies.
Our services include:
- ICSR/SAE/SUSAR case management
- Development Safety Update Reports (DSURs)
- Global and local regulatory compliance (MHRA, EMA, FDA)
- Early signal detection and benefit-risk evaluation
- Seamless integration with CROs and clinical trial teams
Post-marketing pharmacovigilance
We deliver full-spectrum post-marketing safety support to help sponsors meet global obligations and monitor long-term patient outcomes.
Our services include:
- ICSR case processing
- Signal detection and management
- Literature monitoring
- Risk Management Plans and PASS
- PSMF development and maintenance
- QPPV/LPPV provision
- Aggregate safety reports (PSURs, PBRERs, PADERs)
- Real-world evidence and long-term safety surveillance
Pharmacovigilance consulting services
We provide effective consulting services to support regulatory compliance for pharmacovigilance strategy. This includes training and support for in-house teams alongside assistance with safety database setup and reporting processes.
Risk management and signal detection
Sciensus uses advanced data analytics to identify safety concerns early. We implement proactive risk mitigation strategies and provide ongoing monitoring and adaptation to evolving regulatory frameworks.
The Sciensus approach to drug safety and compliance
What sets Sciensus apart is our integration of pharmacovigilance with direct patient engagement. Our approach goes beyond passive reporting by gathering insights directly from patients in real-world settings — enhancing signal quality, improving follow-up, and enabling more meaningful safety outcomes. We bring regulatory precision together with deep healthcare experience to offer a truly patient-centric pharmacovigilance model.
Furthermore, Sciensus has expertise in navigating complex regulatory landscapes across Europe and offers tailored support for pharma, biotech, and healthcare organisations.
Contact Sciensus for pharmacovigilance support
To discover more about our expertise, resources and options in drug safety and pharmacovigilance services, we encourage pharmaceutical companies and clinical trial sponsors to get in touch with us at the earliest opportunity.
30+ years of global PV and regulatory expertise
Flexible, scalable delivery models
24/7 safety case support
Real-world data and digital data integration
How to get started with Sciensus’ pharmacovigilance services
Getting started with Sciensus’ pharmacovigilance consulting services is simple. First, we’ll offer a step-by-step guide for pharma companies and CROs to access Sciensus’ services. Then comes the consultation process where we assess your pharmacovigilance needs. After onboarding and integration with your existing drug safety systems, you can expect ongoing support and compliance monitoring from us.
Get in touch
Thank you for your interest in Sciensus. Whether you’re seeking information, partnership opportunities, or want to refer a patient, our dedicated team is here to assist you. Please fill out the form on the right, and one of our multi-lingual representatives will get in touch with you promptly.
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