Local PV Network

We Help Define Pharmacovigilance Expectations, Not Just Follow Them

When it comes to local pharmacovigilance, credibility matters. Our experts have contributed to international pharmacovigilance guidelines and work closely with health authorities and regulated companies to translate regulatory expectations into real-world practice.

Local Pharmacovigilance Is Where Global Systems Usually Break Down

If you operate across multiple countries, local pharmacovigilance is where complexity turns into risk, often revealed during an inspection. Responsibilities blur, national requirements are interpreted differently, and local practices drift from global processes, creating gaps that are difficult to defend.

Country-Level Pharmacovigilance Support That Closes the Gaps

Local pharmacovigilance only works when responsibilities are clear, activities are consistent, and expectations are understood at country level. Our Local PV Network provides practical, on-the-ground support to help you meet national requirements, maintain continuity, and stay inspection-ready across every market you operate in.

Responsible Person at Country Level and Deputy

You need assurance that local pharmacovigilance responsibilities are always covered. We provide qualified Responsible Persons at country level, supported by trained deputies to always ensure continuity. Our local experts act as your official point of contact with authorities and ensure national safety requirements are met accurately and on time.

Compliance at Country Level

Local pharmacovigilance compliance must be clear and defensible. We support compliance with national PV legislation, guidance, and authority expectations in each country where you operate. Our local experts translate regulatory requirements into practical actions and help you maintain a compliant, inspection-ready local PV system.

Supporting Case Intake and Follow-Up

Accurate and timely case handling is essential for patient safety and compliance. We support local case intake and follow-up activities in line with country-specific requirements. Our experts ensure adverse events are captured correctly, relevant information is obtained efficiently, and cases are managed in accordance with local expectations.

Supporting Process of ARMM:

Risk minimisation measures require consistent and compliant local execution. We support the implementation and maintenance of Additional Risk Minimisation Measures (ARMMs) in line with national authority requirements. Our local experts help ensure ARMM activities are practical, documented appropriately, and ready for inspection.

Supporting Local Inspection and Audit Readiness

Inspection readiness should be continuous, not reactive. We support local inspection and audit preparedness by ensuring documentation, processes, and local PV systems meet authority expectations. Our experts understand how regulators assess compliance and help you respond confidently before, during, and after inspections.

Responsible Person at Country Level and Deputy

Compliance at Country Level

Supporting Case Intake and Follow-Up

Supporting Process of ARMM:

Supporting Local Inspection and Audit Readiness

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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.

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Here’s what working with us actually looks like

Understand your local PV footprint

We start by understanding where you operate, how local responsibilities are currently covered, and where gaps or risk exist at country level.

Put the right local experts in place

We align on expectations and assign qualified country-level experts and deputies with clear roles, responsibilities, and escalation pathways.

Maintain ongoing compliance and inspection readiness

We support day-to-day local PV activities and help you stay prepared for inspections through consistent execution and defensible documentation.

Understand your local PV footprint

We start by understanding where you operate, how local responsibilities are currently covered, and where gaps or risk exist at country level.

Put the right local experts in place

We align on expectations and assign qualified country-level experts and deputies with clear roles, responsibilities, and escalation pathways.

Maintain ongoing compliance and inspection readiness

We support day-to-day local PV activities and help you stay prepared for inspections through consistent execution and defensible documentation.

No fluff. No surprises. Just clarity and accountability.

Practical resources to help you make better PV decisions

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Local Pharmacovigilance, Done Right at Country Level

We Help Define Pharmacovigilance Expectations, Not Just Follow Them

Country-Level Pharmacovigilance Support That Closes the Gaps

FAQ

Here’s what working with us actually looks like

Practical resources to help you make better PV decisions

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