Strategies for Selecting the Right Pharmacovigilance Service Provider

Today’s sponsors need more than just service providers – they require agile, accountable partners who can safeguard data integrity, manage regulatory risk, and respond in real-time. With the PV outsourcing market projected to exceed $10.5 billion by 2030, fueled by rising adverse event volumes and demand for tech-enabled safety systems, the stakes have never been higher.[i] Selecting the right partner is critical to a strategic approach to risk management. The following framework outlines how sponsors can evaluate PV providers in terms of what matters most: quality, compliance, and resilience.

 

 

Quality Is a Metric, Not a Buzzword

“Quality” must be prioritized in any Request for Proposals. This means adhering to the International Council for Harmonisation guidelines, utilizing validated systems, processing cases in a timely manner, and ensuring audit readiness by design. Ask PV service providers for performance data such as processing cycle times, submission timeliness, and deviation rates. According to the European Medicines Agency, from 2001 to 2022, the EudraVigilance database collected more than 25.3 million individual case safety reports, representing 14.8 million unique suspected adverse drug reaction cases.[i] This scale of reporting offers a clear snapshot of the volume, complexity, and urgency that pharmacovigilance teams must manage. In this environment, a PV service partner capable of delivering at scale is essential.

 

Ditch the Demo. Test for Real-World Readiness

Traditional RFPs reveal how a service provider performs on paper. Instead, evaluate how PV service providers think by using scenario-based evaluations to simulate real-world challenges, such as system migrations, sudden influxes of cases, or signal escalation. One sponsor described it as “bid defense 2.0”: a live environment that reveals how service providers apply expertise under pressure. The result? A clearer picture of operational agility, regulatory fluency, and whether the PV service provider team can scale with you as your portfolio evolves.

 

Do Not Just Vet the Pitch Team, Vet the Delivery Team Too

One of the most common mistakes in PV outsourcing is confusing the sales team with the operations team. The people who win the bid may well not be the ones who will manage your safety data on a day-to-day basis. Before you sign the contract, demand visibility into the actual team, review their CVs, assess their turnover history, and verify their domain expertise. High turnover among PV service providers can also slow down operations and fragment institutional memory, thereby undermining process consistency and increasing the risk of compliance violations. Seek out a team that is familiar with your therapeutic area, understands local regulatory nuances, and is proficient in your safety system, whether that’s Argus, LifeSphere MultiVigilance, or another model. Anything less is a risk you can do without.

 

Build Compliance Together Before the Regulators Come Knocking

Regulators have made one thing clear: you can outsource pharmacovigilance activities, but not the accountability that comes with them. When visibility into third-party systems is limited or governance is vague, sponsors risk more than just audit findings; they risk eroding regulatory trust. Treat compliance as a shared responsibility from day one. Co-develop a framework that defines how quality will be measured, reviewed, and escalated before gaps appear in an inspection report. Weekly quality reviews, quarterly audits, and an annual Corrective and Preventive Actions health check are best practices because in a risk-driven environment, the only sustainable strategy is proactive alignment.

 

The Takeaway

Outsourcing PV is about sharing responsibility intelligently. Learn how PrimeVigilance partners with sponsors to deliver the consistency, compliance, and insights that modern pharmacovigilance requires.

 

How PrimeVigilance Can Help

Selecting the right pharmacovigilance partner is a strategic decision—one that directly impacts compliance, data integrity, and regulatory trust. PrimeVigilance’s team of pharmacovigilance experts is deeply embedded in the evolving global regulatory landscape, helping sponsors navigate complexity with confidence.

Contact PrimeVigilance today to discuss how we can support your organization’s pharmacovigilance needs.

 

 

[i] Grand View Research. (2023). Pharmacovigilance market size, share & trends analysis report by service, by clinical trial phase, by process flow, by therapeutic area, by end use, by region, and segment forecasts, 2023 – 2030.

[i] European Medicines Agency. (2023). Annual report on EudraVigilance for the European Parliament, the Council and the Commission – 2022.