Instant Pharmacovigilance Department

PHARMACOVIGILANCE OUTSOURCING

Your pharmacovigilance department,
ready when you are

Most Pharmacovigilance departments are built on process. Ours is built on clinical judgment first. Dr. Seto and his team bring medical reasoning into every function, from case intake to signal evaluation to risk management, so your safety system isn't just compliant, it's defensible. That's the difference a physician-led operation makes.

Case Intake & Processing

Reliable, structured manual or AI-assisted case intake and complete processing workflows tailored to your products and volumes, covering intake, verification, triage, quality checks, and submission readiness so operations stay stable and compliant, even as workload rises.

Signal Management

A complete signal process: detection, augmentation, validation, evaluation, communication, and documentation, supported by modern analytics and medical judgment. We help cut through noise and reach defensible decisions with clarity and confidence.

Regulatory Intelligence & Safety Governance

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.

Latest Technology, Vendor Oversight & Local Partners

The infrastructure your department needs, GXP validated Oracle Argus safety database system, iViSight workflow management with live dashboards, instant line listings, and reports, iViSignal for quantitative signal detection, partner and vendor oversight, local PV support, integrations, migrations, hosting, and governance, so operations stay connected, stable, and inspection-ready.

Medical Review & Clinical Safety

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 every medical decision is well-founded and defensible.

Risk Management

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

PV Quality System & QPPV Oversight

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

Global and Local Literature Monitoring

Systematic global and local literature monitoring aligned with regulatory requirements. We identify, assess, and document relevant safety information so potential risks are captured, evaluated, and incorporated into your PV system without delay.

Writing and Submission of Aggregate Reports

Expert preparation and submission of aggregate safety reports, including PSURs, PBRERs, DSURs, and related deliverables, ensuring data accuracy, medical coherence, and regulatory compliance so submissions are timely, defensible, and inspection-ready.

PSMF Creation & Maintenance

End-to-end PSMF creation and upkeep tailored to your organization, products, and operating model. We design, maintain, and update a clear, compliant master file that accurately reflects your PV system and stands up to regulatory scrutiny at every stage.

UK / EU QPPV

Experienced UK / EU QPPVs and local responsible persons delivering continuous oversight, clear accountability, and regulatory alignment across your markets.

LET'S TALK

Put Your Question to a Pharmacovigilance Expert

Tell us what you're working on, whatever the stage or market. We'll make sure your question reaches the specialist who leads that area, and that you get a real, considered answer back, not a brochure.

Actual iVigeeans ↑

Does It Really Matter if My PV Vendor Is Physician-Led?

Before you compare vendors or talk about outsourcing, you need to understand what great pharmacovigilance leadership really looks like. Dr. Henry Seto answers the question directly, and honestly. Press play to hear what most vendors won't tell you. ↓

More pharmacovigilance insights from people who live it.

From physician-led videos to practical guides and regulatory updates, everything in our Knowledge Hub is designed to help you make confident, informed decisions.

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