Minimize Your Risk and Stay Compliant.

Take the faster, better, smarter approach and discover how we can provide a total solution to all your Pharmacovigilance needs.

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Arriello’s Full Pharmacovigilance System and services.

Failing to properly monitor, assess and report safety concerns puts patients as well as your investment in your Marketing Authorization at risk. That’s why it’s essential to have a proven and robust pharmacovigilance system in place.

Arriello has been a leading supplier of Global and Local Pharmacovigilance services, since 2008. Our team has a combined experience of over 75 years across the EU, US, LATAM, MENA, CIS, APAC regions and South Africa.
We are constantly expanding our global coverage and currently operate in 143 countries with the ability to expand this as required.

Our Full Pharmacovigilance System and services have been developed and refined over several years and are maintained by our in-house European Union Qualified Persons Responsible for Pharmacovigilance (EUQPPVs) and Deputy QPPVs, backed up with the support of a range of Medical specialists.

Whatever your pharmacovigilance needs, our experts can advise, implement and continue to minimize your risks and keep you fully compliant.

Understanding your portfolio and expectations is the key.

To build an optimal PV system solution for our clients, we use expert knowledge of the current and likely legislation, experience, and of course a deep understanding of their portfolio and expectations.

Miroslava Matikova, Arriello EU QPPV and Pharmacovigilance Project Manager, talks about our focused client/compliance/safety approach together with our faster, better, smarter ethos, and how that has really delivered for our clients.

 

"Every client has a different portfolio, with their specific needs and expectations and at Arriello we make sure we really understand what our client’s needs are, currently and with a view to the future, because without that deep client insight you cannot build an efficient, tailored solution or system that matches those requirements to regulation, compliance and patient safety."

The EU QPPV role at Arriello - Miroslava Matikova

Miroslava Matikova
EU QPPV | Pharmacovigilance Project Manager

Thanks Miroslava, you have certainly worked hard over the years and have given Ascot a first class service.

Phillip Gent
Quality Assurance Manager, Ascot Laboratories Limited, UK
(Miroslava Matikova, Arriello EU-QPPV)

Core services.

Monitoring of authorities’ websites
We constantly monitor the EMA (European Medicines Agency) and HMA’s websites for global PV regulatory intelligence applicable for the whole EU and use our findings to advise and update your procedures.

EudraVigilance maintenance
Your Eudravigilance profiles for Production and Testing are registered and maintained by our experienced EU QPPV (Responsible Person) and Deputy EU QPPV (Trusted Deputy). We make sure your medicinal products are entered and updated in the Article 57 database accurately and on time.

PV System setup and maintenance
We are fully responsible for the creation and update of your Pharmacovigilance System Master File (PSMF).

Comprehensive Management of ICSRs.  

Managing your individual case safety reports (ICSR’s) accurately and efficiently is critical to an effective PV system and Arriello provides full support for each step of the ICSR handling process. From confirmation and translations to data entry and archival, we’ll manage your safety data and meet all your ICSR requirements. Our capabilities include MedDRA coding, case assessment, and electronic reporting through EudraVigilance.

Pharmacovigilance Signal Management.

Rely on Arriello for signal management, and gain peace of mind knowing our experts have the in-depth knowledge you need to stay compliant.

From keeping tabs on adverse events in EudraVigilance to helping your organization follow Good Pharmacovigilance Practices (GVP), our team members will help you follow the right regulatory guidelines.

Case study: EU expertise delivers results.

Global Pharmaceutical Generic, Canada

 

This Canadian client, a leading generic pharmaceutical company, was successful in their national market but wanted to expand into Europe. Building an in-house EU Pharmacovigilance System would have required a significant financial investment alongside risk, so they chose Arriello as their partner to deliver a fully tailored system saving cost, time and minimizing risk.

Choosing the right service and people is critical.

Your choice of pharmacovigilance provider can have profound impacts on the success of your products in the marketplace through their life cycles. Ensuring compliance and safety, whilst being able to manage risk and plan around change, requires experience and depth of knowledge.

EU QPPV and Senior Pharmacovigilance Manager Peter Kohut, talks about what he sees as important to provide an excellent pharmacovigilance service for clients.

 

"To be effective, you have to be supported by the right company infrastructure, with in depth knowledge and a great Quality Management system.

And that’s exactly what we have built at Arriello, because these are our foundations of an efficient PV system and an excellent service."

The EU QPPV role at Arriello - Peter Kohut

Peter Kohut
Senior Pharmacovigilance Manager | EU QPPV

Global Literature Monitoring.

Global literature monitoring is a key part of a full GVP (Good Vigilance Practice) based pharmacovigilance system and at Arriello, we screen using Embase with Medline database.

Using broad and narrow literature queries, we search for ICSRs, published studies and information relevant for the safety of your products. We make sure we’ve fully assessed any available information that may impact on patient safety or require further investigation.

Aggregate Safety Reports.

We can handle all your Aggregate Safety Reporting obligations throughout the life-cycle of your product with the creation of Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs).

From compiling your DSUR information to preparing your PSUR for the EMA (European Medicines Agency), we have the knowledge and expertise you need to stay compliant with requirements.

Risk management.

An effective Risk Management System and the development and update of Risk Management Plans, mandatory in the EU, are a critical part of pharmacovigilance and patient safety. If you don’t effectively monitor for Important Identified and Potential Risks or missing information your Marketing Authorization or Application is itself at risk.

Arriello’s in-house risk management expertise can identify new safety concerns and propose appropriate risk minimization measures, keeping you compliant and improving patient safety.

Case study: EU expertise delivers results.

Global Pharmaceutical Generic, Canada

 

This Canadian client, a leading generic pharmaceutical company, was successful in their national market but wanted to expand into Europe. Building an in-house EU Pharmacovigilance System would have required a significant financial investment alongside risk, so they chose Arriello as their partner to deliver a fully tailored system saving cost, time and minimizing risk.

Audit/Inspection Readiness - AIR.

If you’ll soon undergo an audit, you don’t have to face it alone. At Arriello, our experienced team has a deep understanding of the auditing process.

We are audited numerous times each year as part of the auditing process of our clients as they themselves either prepare to be audited or, as part of a health agency inspection, where we are part of the system they maintain. True to our faster, better, smarter ethos, we are fully ISO: 9001 Certified for Quality Management and we are able to offer this expertise as a service.

With our team, you can...

  • Have Arriello audit your organization for best practices through a detailed gap analysis and report.
  • Prepare for a Good Pharmacovigilance Practice (GVP) Audit.
  • Ready your team for a Health Inspection Audit.
  • Learn how to audit internal teams and vendors.

More about support services for audits and inspections.

Pharmacovigilance training.

In addition to our in-house pharmacovigilance services, we can also provide pharmacovigilance training for your specific project or as a standalone service.

Global Pharmacovigilance Network.

We can also offer a completely tailored Local PV service solution to your requirements. For more information, click here.

Current or future requirements for a Full Pharmacovigilance solution?

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