Instant PV Department

A PV department built by people who’ve done this before

You’re supported by safety physicians, QPPVs, regulatory experts, and PV specialists who have built, scaled, and defended real pharmacovigilance departments through inspections, audits, and rapid growth, so your system is designed correctly from day one.

You’re responsible for a PV system that’s outgrowing its setup

As products launch, markets expand, or timelines tighten, case volumes rise, submissions pile up, and expectations increase, often faster than your people, processes, or systems can keep up, leaving all the risk and pressure on you.

A complete pharmacovigilance department, built around you

You get an end-to-end PV department covering every critical function, so your safety system works cohesively, scales with your needs, and stays compliant without constant firefighting.

Case Intake & Case Processing

You get reliable, structured case intake and complete case processing workflows tailored to your products and volumes. We handle intake, verification, triage, processing, quality checks, and readiness for submissions so your operations stay stable and compliant, even as workload rises.

Medical Review & Clinical Safety

You get physician-led medical review, benefit–risk assessment, and clinical interpretation across development and post-marketing. Our experts provide clarity for complex cases, data inconsistencies, protocol questions, and emerging trends so you can stand behind every medical decision with confidence.

Literature Monitoring, Submissions & Aggregate Reporting

You get end-to-end literature monitoring, global and local submissions, and preparation of DSURs, PSURs, PBRERs, and PADERs. Everything is aligned with regulatory expectations, medically sound, and delivered with consistency so nothing slips through the cracks.

Signal Management

You get a complete signal process, detection, augmentation, validation, evaluation, communication, and documentation, supported by modern analytics and medical judgment. We help you cut through noise and make defensible decisions with clarity and confidence.

Risk Management

You get RMP development, lifecycle management, aRMM design and execution, and effectiveness evaluation. We build risk systems that protect patients, satisfy regulators, and support you with clear reasoning when expectations evolve or evidence shifts.

Regulatory Intelligence & Safety Governance

You get expert-led monitoring of global PV requirements, impact assessments, curated updates, and actionable guidance that tells you exactly what changes mean for your products, without the noise or ambiguity.

PV Quality System & QPPV Oversight

You get a complete PV quality framework, SOPs, PSMF, audits, inspection readiness, quality oversight, and QPPV office support, all designed to keep your system aligned, documented, and defensible across every market you operate in.

Technology, Vendor Oversight & Local Partners

You get the infrastructure your department needs - validated safety systems, partner and vendor oversight, local PV support, integrations, migrations, hosting, and governance. Your operations stay connected, stable, and inspection-ready without you having to manage the technical or operational burden yourself.

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.

How we build your instant PV department

You show us what’s happening in your safety world

You walk us through your products, timelines, systems, and where your current setup feels stretched or incomplete. This helps us understand your real workload and expectations, so we build a department that fits your reality.

We design a PV department around your needs

You receive a clear plan across the core PV pillars, what’s included, who does what, how oversight works, and the timelines you can expect. Everything is transparent before anything begins.

You get a fully functioning PV department that scales with you

Your department is stood up quickly with the expertise, processes, governance, and technology you need from day one. As your portfolio grows or priorities shift, your PV function adapts with you, without adding stress to your day.

You show us what’s happening in your safety world

We design a PV department around your needs

You receive a clear plan across the core PV pillars, what’s included, who does what, how oversight works, and the timelines you can expect. Everything is transparent before anything begins.

You get a fully functioning PV department that scales with you

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.

A complete pharmacovigilance department, ready when you are

A PV department built by people who’ve done this before

A complete pharmacovigilance department, built around you

FAQ

How we build your instant PV department

Practical resources to help you make better PV decisions

PV Consulting

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