Instant PV Department

Pharmacovigilance services designed to scale with you

Whether you’re building a PV function, strengthening day-to-day operations, or preparing for more complex transformation, you get physician-led services that meet you where you are and help you move forward with clarity and control.

Physician-led pharmacovigilance, grounded in real regulatory experience

When you rely on support across multiple areas of pharmacovigilance, you need judgment you can trust. You’re supported by physician-led teams with hands-on inspection and regulatory experience, so guidance reflects how PV is evaluated in practice, not just how it’s written.
CIOMSCIOMS
EMAEMA
FDAFDA
Health CanadaHealth Canada
ICHICH
MHRAMHRA
PMDAPMDA
WHOWHO

Your PV needs change as complexity grows

As your organization evolves, what works in pharmacovigilance today may not work tomorrow. New products, markets, and expectations quickly stretch existing systems and processes.

You may be building a PV function, optimizing operations, or preparing for more advanced transformation. At every stage, you’re still expected to stay compliant, inspection ready, and confident in your decisions, often with limited visibility.

You deserve support that meets you where you are and helps you move forward as your responsibilities change.

Built around your products, 
your timelines, and your reality

Our Instant PV Department adapts to your needs via eight core pillars. We cover every critical function to ensure a high-performing, stress-free system.
UK/EU Qualified Person for Pharmacovigilance
UK/EU Qualified Person for Pharmacovigilance
You get experienced EU QPPVs who serve as your primary contact with authorities, ensuring legal responsibilities are fulfilled. We support appointments, transitions, and continuity planning so compliance risk stays low and accountability remains clear.
Instant Pharmacovigilance Department
Instant Pharmacovigilance Department
You get a complete operational department covering case processing, medical review, signal management, risk management, regulatory intelligence, quality systems, technology infrastructure, literature monitoring, reporting, and inspection readiness. Your entire operation stays stable, compliant, and inspection-ready.
Qualified Pharmacovigilance Experts
Qualified Pharmacovigilance Experts
You get experienced professionals including interim Heads of Safety, QPPVs, regional leads, safety physicians, systems experts, and scalable consultants. Our experts fill leadership gaps, provide medical expertise, manage technology, and deliver flexible resourcing that scales without sacrificing compliance.
Vendor Management
Vendor Management
You get end-to-end vendor management covering advisory services, independent qualification and audits, ongoing oversight and performance tracking, and structured management of pharmacovigilance and clinical trial vendors. Your vendor landscape stays aligned, transparent, and defensible.
Local Pharmacovigilance Network
Local Pharmacovigilance Network
You get coordinated local support including qualified Responsible Persons at country level, local compliance support, case intake assistance, risk minimization implementation support, and inspection readiness. We serve as your single point of contact with national authorities.
Data Management and Case Processing
Data Management and Case Processing
You get structured case management covering intake solutions, physician-led medical review, complete processing workflows, reliable submission, aggregate report preparation, and ongoing safety oversight. Your data stays clean, consistent, and inspection-ready from intake through submission.
Signal Management
Signal Management
You get complete signal management covering advanced detection using analytics and AI, signal augmentation combining internal and external data, medical and statistical validation, clear communication, and full traceability through comprehensive tracking and audit trails.
Risk Management
Risk Management
You get comprehensive risk management covering RMP development and lifecycle management, end-to-end system setup and oversight, and risk minimization measure design, execution, and effectiveness evaluation. Your risk systems protect patients, satisfy regulators, and support clear reasoning.
Quality Management and Assurance
Quality Management and Assurance
You get complete quality oversight covering SOP development and maintenance, PSMF setup and upkeep, audits and inspection support with gap assessments, and continuous oversight across all activities including partners, processes, data flows, and documentation.
Pharmacovigilance Technology
Pharmacovigilance Technology
You get comprehensive technology support covering Oracle Argus implementation, iViSight for analytics, iViReg for regulatory intelligence, iViNet for partner collaboration, migrations and integrations, and managed services including hosting and tech governance. Your systems stay reliable and inspection-ready.
Regulatory Intelligence
Regulatory Intelligence
You get complete regulatory intelligence through iViReg and our Regulatory Intelligence Team who monitor changes at the source. We deliver timely impact assessments, organize requirements into clear knowledge systems, and provide tailored news feeds so you know what's expected.
Clinical and Medical Safety
Clinical and Medical Safety
You get strategic support covering clinical trial safety monitoring and reporting, medical safety expertise for development products including review and benefit-risk assessment, and protocol development and review support for study designs, safety language, and risk management plans.
AI Transformation
AI Transformation
You get AI transformation support covering literacy training, strategic roadmap design showing where AI adds value, AI implementation in case processing and signals that keeps you in control, and validation support that makes every system transparent and defensible.
Pharmacovigilance Training
Pharmacovigilance Training
You get comprehensive training covering legislation and module training, AI masterclasses, in-house customized programs designed around your workflows, professional certification opportunities, auditor training, and inspection readiness training using practical examples that prepare teams for regulatory interactions.
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.