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.

We’ve provided PV services since 2008, and our team has experience in the EU, LATAM, MENA, CIS, and APAC regions with a combined experience of over 45 years.
Our global vendor network includes 128 companies in 92 countries.

Our Full Pharmacovigilance System and services have been developed and refined over several years and is maintained by our in-house European Union Qualified Person Responsible for Pharmacovigilance (EUQPPV) and Deputy QPPV, 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.

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

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.

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.

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.

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.

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, 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.

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.

Current or future requirements for a Full Pharmacovigilance solution?

Find out how our faster, better, smarter service can meet and surpass them.