Data Management & Case Processing

Safety data managed by people who know what “right” looks like

You’re supported by physicians and pharmacovigilance experts who have fixed broken data flows, supported inspections, and contributed to the guidelines regulators rely on, so your safety data is accurate, consistent, and inspection ready from the start.

You shouldn’t spend your time fixing other people’s data

Safety data often arrives incomplete, inconsistent, or without the medical context you need, leaving you to reconcile sources, chase clarifications, and clean information under pressure, all while deadlines, inspections, and reporting obligations keep moving.

How we bring order and clarity to your safety data

You get structured support across the entire safety data lifecycle, so information is complete, medically sound, and ready when you need it, without constant rework.

Intake Solutions

Your data journey starts with intake, and you deserve a process that’s consistent from the beginning. We help you set up structured, reliable flows so information from patients, HCPs, partners, affiliates, and literature arrives clean and complete. When your inputs are stronger, everything else becomes easier.

Medical Review

You shouldn’t have to question the clinical accuracy of your data. Our experts provide clear, consistent assessments of seriousness, causality, and medical relevance so you always know where you stand. With expert oversight built in, your data becomes more reliable and inspection ready.

Literature Monitoring

Literature should support your decisions, not overwhelm your team. We combine automation with expert evaluation to filter out the noise and surface what truly matters. You get clean, defendable findings that integrate smoothly into your downstream processes.

ICSR Submissions

You deserve submission workflows that feel predictable, not stressful. We support your global and local submissions with clear timelines, transparent documentation, and full visibility at every step. You stay in control without carrying the burden alone.

Aggregate Reports

Your periodic reports should reflect strong data, not last-minute scrambling. Because your inputs are structured and medically validated, we prepare DSURs, PSURs, PBRERs, and PADERs with clarity and consistency. The result is reporting you can approach with confidence.

Intake Solutions

Medical Review

Literature Monitoring

ICSR Submissions

Aggregate Reports

Build a PV Department That Fits Your Timeline

Stop managing the burden of building from scratch. Get more information on our fully integrated modules and discover exactly how we stabilize your safety operations.

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?

Still have questions?Can't find the answer you're looking for? Please chat to our friendly team.

Here’s how working with iVigee actually works.”

We understand your data flow

You walk us through your sources, systems, partners, and pain points. We take the time to understand how your safety data really moves today—no assumptions and no one-size-fits-all models.

We design a data approach that fits your reality

You see exactly how data will flow, who is responsible at each step, what medical oversight is applied, and how long things take. Timelines, responsibilities, and expectations are clear before anything begins.

You get ongoing support that keeps data inspection ready

We work alongside you with structured workflows, physician-led review, and transparent communication. As your needs evolve, we adjust with you so your safety data stays clean, consistent, and inspection ready.

We understand your data flow

You walk us through your sources, systems, partners, and pain points. We take the time to understand how your safety data really moves today—no assumptions and no one-size-fits-all models.

We design a data approach that fits your reality

You get ongoing support that keeps data inspection ready

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.

Safety data management you can rely on

Safety data managed by people who know what “right” looks like

How we bring order and clarity to your safety data

FAQ

Here’s how working with iVigee actually works.”

Practical resources to help you make better PV decisions

PV Consulting

Knowledge Hub