Pharmacovigilance is the science and set of activities involved in detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. It runs across the entire product lifecycle, from first-in-human clinical trials through marketing authorization and ongoing post-authorization monitoring.

You need PV obligations covered as soon as you have a product in a regulated market, and clinical-stage companies already carry safety responsibilities such as SAE and SUSAR handling and DSUR reporting. The earlier a PV system is built, the easier it is to scale from clinical development to commercial launch without costly rework.

An Individual Case Safety Report (ICSR) is the structured record of an adverse event associated with a medicinal product for a single patient. ICSRs are processed, quality-checked, and submitted electronically to the relevant health authorities within defined regulatory timelines.

A Qualified Person Responsible for Pharmacovigilance (QPPV) is a named, 24/7-available individual who oversees a company's PV system in the EU or UK. Any marketing authorization holder operating in these regions is required to appoint and register a QPPV, along with a deputy for continuity.

Aggregate reports periodically summarize the safety profile of a product over a defined interval rather than case by case. DSURs (Development Safety Update Reports) cover investigational products in clinical development, while PSURs/PBRERs cover authorized products on the market.

Outsourcing gives you immediate access to qualified experts, validated systems, and an established quality framework without the cost and time of building them yourself. iVigee can act as an extension of your team, so you can focus on commercial growth without compliance anxiety.

Look for regulatory expertise, a robust and audited quality management system, global and local market coverage, and a single accountable point of contact rather than a patchwork of vendors. A proven inspection and audit track record is also a strong indicator of reliability.

Yes. iVigee's model is designed to scale from a clinical-stage biotech needing a foundational PV setup to large pharma requiring high-volume global case management. The same partner can grow with you from clinical development through commercial expansion, avoiding disruptive transitions.

No. Smaller companies often benefit the most because they typically operate with lean internal teams and still carry full marketing authorization holder obligations. A partner can effectively serve as a "PV department-in-a-box," bundling QPPV, operations, and oversight in one place.

iVigee is physician-led and positions itself as a boutique, high-touch provider with centers of excellence in Boston and Prague plus a network of local experts. The team backs its work with a guarantee: no critical findings, or it will resolve them at its own cost.

iVigee provides end-to-end support spanning consulting, operational PV services, safety database management, and compliance. This covers case processing, aggregate reporting, signal management, QPPV services, literature monitoring, regulatory intelligence, and quality and audit support.

Yes. The service model is built so clients can choose whatever combination of services fits their situation rather than committing to a fixed bundle. This lets you cover only the gaps you have, whether that's a single QPPV appointment or a full managed-services arrangement.

Yes. iVigee offers EU/UK QPPV and deputy services, including appointment and registration in EudraVigilance, as well as local QPPVs and a local PV network. This helps reduce compliance risk in markets that can be hard to serve.

Yes. iVigee can perform a gap analysis, build the PV system, create and update SOPs, define KPIs, and manage partnership agreements such as PVAs and SDEAs. This is particularly valuable for companies preparing for their first trial or launch in a regulated market.

iVigee specializes in Oracle Argus Safety, with an in-house team covering configuration, validation, analytics, reporting, and infrastructure. Services include implementation, configuration, managed services, and ongoing support.

A single-tenant environment offers dedicated infrastructure, complete data isolation, and full customization, while a multi-tenant environment shares infrastructure for greater cost efficiency, faster access to new features, and elastic scalability. The right choice depends on your security, compliance, customization, and budget priorities.

A single-tenant environment offers dedicated infrastructure, complete data isolation, and full customization, while a multi-tenant environment shares infrastructure for greater cost efficiency, faster access to new features, and elastic scalability. The right choice depends on your security, compliance, customization, and budget priorities.

Yes. iVigee performs Argus-to-Argus migrations using approaches tailored to your source and destination setup, including single-tenant and multi-tenant configurations. Migrations use methods such as lift-and-shift, full database export, and E2B export/import depending on the scenario.

Managed services cover day-to-day operational needs such as application and configuration support, query and reporting issues, system monitoring, user access management, MedDRA and WHO Drug dictionary upgrades, E2B partner setup, and configuration change control. On-site support during regulatory inspections is also available when needed.

iVigee supports clients before, during, and after inspections. Pre-inspection work includes readiness plans for unannounced inspections, mock inspections and hosting training, gap analysis, and review of prior CAPAs.

During an inspection, iVigee provides full inspection management and hosting, ensures appropriate subject-matter experts attend interviews, and manages timely provision of requested documents. The goal is a controlled, well-prepared process that supports a successful outcome.

After an inspection, iVigee helps develop quality, timebound CAPA (Corrective and Preventive Action) responses and ensures the quality assurance team follows all actions through to completion. An effectiveness assessment is then carried out to confirm the actions worked.

Engagements usually begin with an entry deal sized to your stage, such as a PV Foundations Pack of SOPs and workflows for an early-stage company, or an MAH Compliance Pack with QPPV, PSMF, and local PV persons for a commercial company. The starting point is shaped by your immediate triggers, such as an upcoming launch, a DSUR deadline, or a QPPV gap.

Yes. iVigee is oriented toward long-term relationships and lasting solutions, acting as a single accountable partner across PV operations and local coverage. Many clients use it as an ongoing department extension rather than for one-off projects.