Pharmacovigilance
Regulatory Compliance at the Forefront of Patient Safety
Comprehensive, compliant pharmacovigilance solutions. Scalable cost-effective case processing staffing models.
Qualified Pharmacovigilance Partner of Choice
Industry-leading experience and innovation
UBC, a leader in pharmacovigilance services, combines deep clinical expertise with innovative technologies to enable biopharmaceutical industries to support global and local pharmacovigilance regulatory compliance across the product lifecycle, from initial clinical development to post-marketing surveillance, for all product types (drugs, medical devices, vaccines, combination products, cosmetics, and gene therapy supplements).
Led by a team of pharmacovigilance experts, we have a deep understanding of the complex and rapidly evolving safety landscape and regulations, as well as risk minimization strategy. We are supported by an unmatched technology suite and operate on the principle that patient safety is a critical industry responsibility.
* From 2018 to Q2 2025
Pharmacovigilance Difference
Full-Service Pharmacovigilance Outsourcing
Pharmacovigilance is vital for drug development and establishment of a product’s benefit-risk profile, and choosing the right partner is critical for success. UBC enables our customers to identify and manage potential risks associated with their products, maintain patient safety, and ensure high regulatory compliance throughout the drug development and commercialization process.
Technology
UBC provides purpose-built pharmacovigilance software solutions to drive efficiency, accuracy, and quality of the PV program through the automation of critical PV business processes including real time signal detection and management, literature review, safety case processing and reporting.
Collaboration
UBC partners with customers to ensure services align with business objectives and regulatory requirements necessary to deliver a robust, compliant PV program. Through collaboration, participation, and transparency, supported by an established governance model, we serve as an extension of our sponsor’s PV team to provide comprehensive pharmacovigilance support.
Customization
UBC offers flexible PV solutions to address the sponsors unique needs and program requirements.
Global Reach
Partnering with sponsors globally, UBC has a thorough understanding of the global and regional PV regulatory landscape. Our PV Process Excellence Team, comprised of safety regulatory intelligence experts, continually evaluates regulatory information to ensure we are current on local PV requirements for all countries of interest.
Pharmacovigilance Services
Our pharmacovigilance strategies combine tenured drug safety expertise, deep regional and local regulatory knowledge, innovative cloud-based pharmacovigilance technology solutions, and process automation to deliver comprehensive, compliant solutions and unmatched insights.
Full-Service Outsourcing
Comprehensive, end-to-end service model enabling sponsors to have high-level oversight of their program while UBC holistically delivers against all facets of the PV program. UBC services include pharmacovigilance safety database services (including configuration and maintenance), case processing from intake through regulatory submissions, case exchange with partners/affiliates, safety writing, signal detection, global and/or providing local literature screening, and safety regulatory intelligence. European post-marketing activities include serving as a Qualified Person for Pharmacovigilance (QPPV), establishing a Pharmacovigilance System Master File (PSMF), handling Eudravigilance registration, as well as local QPPVs / National Contact Persons for the EEA countries, UK, and Switzerland.
Safety Case Processing & Reporting
Experienced team of healthcare professionals with a deep understanding of the regulatory reporting requirements and nuances of the product safety profile, underpinned by technology-enabled case processing services, to support clinical trials, post-marketing studies, and spontaneous reporting.
Literature Review
Global and local literature screening, review, and tracking, leveraging a validated tool informed by literature review requirements, to identify potentially relevant safety information and safety reports.
Safety Writing
Proficient assessment of safety data and preparation and delivery of aggregate safety reports including Periodic Adverse Drug Experience Reports (PADERs), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs).
Frequently Asked Questions
What's included in UBC's full-service pharmacovigilance offering?
UBC’s full-service model covers the day-to-day operation of a pharmacovigilance function – from safety database management and case processing through to signal detection, literature screening, safety writing, regulatory intelligence, and global submissions. We also provide QPPV services, PSMF management, EudraVigilance support, and local PV leadership across Europe. Around 70% of UBC clients choose this fully outsourced model.
Can UBC act as our safety department, or only as a vendor?
Both. For many emerging biotechs, UBC operates as the safety function itself – helping make hiring decisions, author SOPs, select safety databases, and build the processes needed to scale as adverse event volumes increase through development. For larger sponsors, UBC more often supports a defined area such as case processing, aggregate reporting, or signal management alongside internal teams. The right model depends on how the function is structured and where accountability sits.
How does UBC compete with offshore case processing on cost?
By being clear about where each model fits. Offshore teams are well suited to high-volume, lower-complexity case processing where speed and cost are the primary drivers. UBC’s full-service model is built for therapies where adverse events are clinically serious, the case mix is more complex, or the science is still emerging – including rare disease, cell and gene therapy, oncology, paediatrics, and psychedelics. We work with offshore partners where it makes sense, but most sponsors are paying for judgement at intake and during signal review, not data entry.
What technology does UBC use for case processing?
UBC operates a fully cloud-based Oracle Argus environment, supported by validated tools for literature screening, signal detection, and regulatory submissions. Automation helps reduce manual handling and shorten triage times, allowing teams to focus attention where judgement matters most. The technology is consistent with industry standards. The difference is the expertise behind it – the people making decisions, identifying risks, and ensuring the work stands up to scrutiny.
How does UBC handle signal detection and management?
UBC combines aggregate-level signal detection with case-by-case clinical review to identify potential safety concerns, assess their significance, and determine when further investigation or regulatory action may be needed. Our approach aligns with FDA guidance, EMA GVP Module IX, and CIOMS VIII, drawing on broad data sources and appropriate patient populations to ensure signals are interpreted in the right clinical context.
What does UBC's compliance track record actually look like?
From 2018 through Q2 2025, UBC supported 30 regulatory inspections with no critical findings. More than 99% of regulatory submissions are delivered on time, across 70,000+ cases processed annually. Those numbers reflect something important: systems perform better under scrutiny when they’re shaped by experienced people from the start, not assembled under pressure.
How does UBC support periodic and aggregate safety reporting?
UBC prepares PADERs, PSURs, PBRERs, and DSURs throughout the product lifecycle – from the more frequent reporting required for new therapies through to annual reporting as the safety profile becomes better understood. The work is led by clinicians with advanced degrees, with a focus on reports that tell a clear benefit-risk story rather than simply restating the data.
Learn More About UBC's Pharmacovigilance Services
Interested in learning more about how UBC’s pharmacovigilance services can help you make more informed decisions earlier and meet regulatory requirements?
