Risk Management

Risk management you can defend with confidence.

You get clear, regulator-aware support for pharmacovigilance risk management, so your RMPs, risk minimisation measures, and decisions are grounded in evidence, aligned with expectations, and ready to stand up under scrutiny.

Risk management guided by real-world PV experience

You’re supported by PV specialists who have built and maintained RMPs, designed and executed aRMMs, evaluated effectiveness, and defended decisions during inspections, so your risk management is grounded in evidence, medical judgment, and how regulators actually assess it.
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You’re expected to manage risk, even when the evidence isn’t clear

Risk management rarely comes with complete certainty. Evidence evolves, signals shift, and expectations vary across teams and regulators, yet you’re the one expected to decide what matters, choose the right measures, and justify every decision in a way that will hold up later.

Risk management rarely comes with complete certainty. Evidence evolves, signals shift, and expectations vary across teams and regulators, yet you’re the one expected to decide what matters, choose the right measures, and justify every decision in a way that will hold up later.

How we strengthen and support your risk management

You get practical, defensible risk management support, so your decisions are evidence-based, aligned with regulatory expectations, and easier to justify as situations evolve.
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FAQ

How do I know if this service is the right fit for my situation?
Every iVigee service is designed to meet you where you are. Whether you’re building a PV function, stabilizing operations, or preparing for more complex change, the right fit depends on your products, timelines, and current pressures. When you reach out, we focus on understanding your reality first, not pushing a predefined solution. From there, we’ll help you determine whether this service makes sense now, later, or not at all.
Can services be tailored, or are they delivered as fixed packages?
Will iVigee work alongside our internal team and existing vendors?
What happens after I request information about a service?
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Here’s how we support your risk management decisions

You tell us where the risks and pressures are
You walk us through your product, current RMP or aRMM status, evidence base, and the areas that feel unclear, complex, or difficult to justify. We take time to understand your timelines and regulatory context, no assumptions and no templates.
We build a risk management plan you can defend
You receive clear recommendations covering RMP updates, aRMM design, effectiveness evaluation, or system improvements. Timelines, responsibilities, and scope are defined upfront, so you know exactly what’s included and why.
You get risk management support that adapts as evidence evolves
We help implement the plan, strengthen justifications, coordinate cross-functional input, and ensure documentation is inspection ready. As data and expectations change, we adjust with you, so your risk management stays aligned, defensible, and under control.
No fluff. No surprises. Just clarity and accountability.

Practical resources to help you make better PV decisions

Explore practical tools, insights, and resources designed to help you make confident PV decisions at your own pace.
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