Safety and Pharmacovigilance Services
Comprehensive global pharmacovigilance strategies for complete product lifecycle support
As a trusted pharmacovigilance CRO, our safety and pharmacovigilance teams support clinical trial and post-marketing safety services across the globe.
With patient safety as the foundation of clinical development, our proven pharmacovigilance strategies align with your objectives to provide both standalone and fully integrated services throughout your product’s lifecycle.
Dual recognition. Proven leadership.
Syneos Health has been named a leader in both pre- and post-approval pharmacovigilance services by Everest Group. This recognition validates our position as a premier pharmacovigilance CRO delivering exceptional outcomes. Read the full report.
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How does Syneos Health meet the challenges of global safety and pharmacovigilance?
Whether you’re looking for full safety services or standalone elements, we’ll partner with you to design flexible, custom-built solutions for compliant and accurate global pre- and post-approval pharmacovigilance, crafted specifically for you.
Our approach to pharmacovigilance focuses on adaptability and centers on our belief that true, forward-thinking innovation – the kind that delivers real-time impact and measurable value – is best achieved by collaboration and co-creation.
Harnessing purpose-built technologies to fuel operational excellence
Innovation and technology are at the core of our ability to deliver operational excellence, quality control and oversight. For example:
- Our proprietary platform, PV Hub, is a real-time Microsoft Azure-based platform developed by Syneos Health to perform and track individual case safety report (ICSR) quality control (QC) review, QC metrics and overall ICSR workflow that is required for our case processing projects. Configurable and validated, PV Hub has the flexibility to accommodate customer-specific processes and systems and provides workflow management within a single view to optimize case allocation and prioritization across single or multiple projects.
- PVCI (PV Case Intake) is our proprietary, Gen AI-enabled, E2B(R3) compliant case intake platform, purpose-built by us to automate email ingestion, structured data extraction, source documentation packaging and query generation. With PVCI, AI handles the heavy lifting—extracting structured data from source documents at intake—while the human-in-the-loop model ensures accuracy by reviewing and correcting the data upfront. Resolving issues early helps reduce downstream errors and improve overall case quality, consistency and processing stability across the workflow.
Our safety and pharmacovigilance advantage
- 1,700+ world-class staff spanning 6 continents: Stable and experienced, including in-house regulatory intelligence team, with 200+ associates in Japan and 125+ associates in China to provide strong regional support
- 350+ audits/inspections involving safety/PV in 2023 and 2024 with no critical findings
- 99.5% critical field quality (2024) leading to robust downstream outputs and signal management
- 99.5% compliance to regulatory authorities (2024) with use of innovative tracking technologies, robust processes
- 11.6% low annual turnover (2023/2024) fully invested teams
- 10+-year customer partnerships with multiple top-20 pharma companies based on demonstrated ongoing process improvements and efficiency gains
Offering you safety and pharmacovigilance services across the product lifecycle
Phase I-III
- Global safety database provision
- Case processing and submissions
- PV regulatory intelligence
- Development Safety Update Report (DSUR)
- Literature search for DSUR
- Development risk management plan
- Clinical trial PV quality system support
Transition to Market
- Pre-marketing PV quality system support
- EudraVigilance (EV) support
- Signal detection and management
- PADER/PSUR/PBRER authoring
- Company Core Safety Information (CCSI)
- Risk Management Plan
- Qualified Person for Pharmacovigilance (QPPV) nomination
Post-Marketing and Phase IV
- Case processing and submissions
- PV regulatory intelligence
- Global and local literature search/review
- Aggregate report authoring
- Signal detection and safety surveillance
- Global risk management
- Qualified Person for Pharmacovigilance (QPPV)
- Local PV network strategy and implementation
- Call center and medical information
- Post-marketing PV quality system support
- PV system gap analysis
Why choose Syneos Health as your safety and pharmacovigilance CRO?
We maintain one of the largest safety and pharmacovigilance teams in the industry, working across the globe exclusively for you. Each project benefits from pharmacovigilance professionals strategically located to support specific requirements. Local staff ensure regulatory reporting compliance while following global processes for consistency.
Our team comprises professionals with strong academic backgrounds, including pharmacists, medical doctors, nurses and life-science graduates. Through 25+ years of safety operations, we've developed deep legislative knowledge and broad industry experience.
We achieve >99% compliance in on-time safety reporting within a constantly evolving regulatory environment. Our successful approaches to pharmacovigilance deliver:
- Case processing excellence: Quality, regulatory-compliant, data-driven delivery, flexible to changing needs
- Clear communication: Transparent planning, routine status updates and collaborative problem-solving
- Prioritized workflow management: Cases prioritized to ensure compliance with closely monitored turnaround times
- Built-in flexibility: Resourcing models that flex during buffer periods, leave and holidays to accommodate unanticipated spikes
- Centralized submissions structure: Global processes ensuring compliance with centralized tracking in PV Hub
- Central quality team: Our unique centralized quality team drives efficiency, alignment and excellence—breaking silos, standardizing best practices, and accelerating smarter decisions and results.
Syneos Health is a core provider of literature search services to multiple customers, offering access to first-hand knowledge of industry best standards and practices. Since July 2015:
- >1 million literature reviews processed annually
- ~90,000 abstracts reviewed monthly
- Flexible resource model providing dedicated support for both low and high volumes
Our skilled writers author PBRERs, DSURs, ASRs, PADERs, ACOs, Clinical Overview Safety Updates, CCSI, CCDS, and RMPs. We take complete ownership from initiation through kick-off meetings to final submission, working across multiple time zones to ensure timely completion.
Our Safety Review Suite, a Spotfire-based system aggregating data from multiple sources, enables users to access data interactively through customized dashboards. Our pharmacovigilance strategies for signal detection include:
- Continuous monitoring: Reviews of adverse events, clinical and post-market data, literature, authority databases, and websites
- Signal detection: Triage, validation, prioritization, and assessment
- Safety signal review meetings: Scheduled meetings chaired by dedicated physicians and qualified persons
- Benefit-risk assessment: Evaluation and endorsement of risk assessments with recommendations for action
As part of our comprehensive approaches to pharmacovigilance , Syneos Health provides QPPV services with professionals who possess:
- EU and UK expertise recruited from our experienced, well-seasoned staff
- Outsourcing model experience acting as QPPV and deputy QPPV for various products
- Strong knowledge of EU PV requirements with capability to build Global PV Quality Management Systems
- Gap analysis services to help build or refine your PV system
- KPIs and reporting to monitor compliance and performance
- Proficiency in local PSMFs, SDEA writing and negotiation, RMPs, inspection readiness, deviation management, and PV root cause analysis
Our local pharmacovigilance model includes the ability to nominate local safety officers (LSOs), who are responsible for set-up, maintenance, and oversight on the local PV system in countries that require it.
AI-driven signal detection, real world evidence integration and predictive analytics are transforming pharmacovigilance. These innovations enable earlier identification of safety risks, more robust risk mitigation and stronger regulatory alignment. Syneos Health leverages these advancements—along with global regulatory expertise and purpose-built technology—to help customers proactively manage safety across the product lifecycle, from clinical development through post-market surveillance.
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