Minimize Your Risk and Stay Compliant.

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

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Arriello’s Global and Local Pharmacovigilance Services.

Failing to properly monitor, assess and report safety concerns puts patients as well as your investment in your Marketing Authorization at risk.

A poor translation can lead to a misunderstood critical report. An article on an adverse reaction buried in a local scientific journal can go undetected. A follow-up on a case isn’t carried out. All these errors can lead to a significant level of risk with non-compliance of regulatory requirements, major or critical inspection findings, and patient safety.

And that’s why the quality and efficiency of the processes and management of your PV system are critical.

Arriello has been a leading supplier of Global and Local Pharmacovigilance Services, since 2008. Our team has a combined experience of over 100 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.

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

Faster, better, smarter within Pharmacovigilance.

How does our faster, better, smarter ethos apply to pharmacovigilance? What does it mean in practice for clients, and for patient safety?

Anna Lukyanova, Arriello's COO talks about how we integrate these 3 principles into our pharmacovigilance service for maximum effect.

 

"In pharmacovigilance, faster is a much more focused concept because it has a patient safety and compliance implication - it is critical for us to be fast to respond to serious cases and to respect client and authority deadlines.

I’m really proud to say that our pharmacovigilance team truly embraces and integrates the fundamental principles of faster, better, smarter in their work on a daily basis, and that it helps them to focus and achieve the best possible outcomes for our clients and for patient safety."

Faster, better, smarter PV at Arriello - Anna Lukyanova

Anna Lukyanova
COO

Throughout the project you have approached the ICON-Arriello relationship with a friendly, constructive and collaborative attitude. I personally appreciated your valuable support, professionalism and conscientiousness. In the face of conflicting priorities and multiple customer demands you remained composed and professional.

Donna Hartley
Drug Safety Manager, Pharmacovigilance and Safety Services, ICON plc, Ireland

Global Pharmacovigilance Services.

Our Global 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 (EU QPPVs) and Deputy QPPVs, backed up with the support of a range of Medical specialists.

Our comprehensive range of services includes...

PV System setup, maintenance and EU QPPV Services.

We are fully responsible for the creation and maintenance of your Pharmacovigilance System Master File (PSMF) and ensuring your PV system is fully compliant with European and International regulations and guidelines through our team of experienced EU QPPV's and Deputy EU QPPV's.

We constantly monitor the EMA (European Medicines Agency), HMA , Official Jourmal of the EU, CIOMS and ICH websites for global PV Regulatory Intelligence updates and advise on the impact to your procedures and medicinal products.

Comprehensive ICSR Management.  

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 collection and translations to data entry, quality check, medical review and submission, 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 Practice (GVP), our team members will help you follow the right regulatory guidelines.

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.

Director of Drug Safety and EU QPPV 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
Director of Drug Safety | EU QPPV

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.

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.

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 Deputy Director of Drug Safety, 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
Deputy Director of Drug Safety | EU QPPV

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)

Local Pharmacovigilance Services.

We can create an efficient, high quality and completely tailored Local PV service solution to all your requirements around the world. Our global coverage is extensive and we currently operate in 143 countries with the ability to expand this as required.

Our comprehensive range of services includes...

LPPV - Local Person Responsible for Pharmacovigilance.

Through consultation and our extensive experience and knowledge of local PV requirements, we know what is required in each market and how that matches your requirements. We can then provide either a LQPPV - local qualified person for pharmacovigilance service, or a LCPPV - local contact person for pharmacovigilance service where this is legally required.

We can do this in all your markets through our comprehensive international vendor network which is qualified and audited by our dedicated vendor management department.

Drug Safety Officer.

Where an LPPV is not legally required we can provide the services of a DSO – Drug Safety Officer, a growing role in Pharmacovigilance. This role is often connected/interchangeable with the title LSO - Local Safety Officer and others which can differ country by country and client by client.

The DSO role objective is primarily the same regardless of title; to have a dedicated knowledgeable and efficient technical service at the individual country/territory level.

At Arriello we offer a unique blend of in-house resource and expertise, combined with local in-country staff who fully understand local regulations. This includes but not limited to Individual Case Safety Reports (ICSR) intake and local level processing, local submissions (aggregate reports, RMPs, ICSRs, etc.), compliance monitoring, the implementation of local PV requirements in relevant procedures and systems, providing PV/product-specific training, Health Authority inspections and many more! As the role is flexible depending on individual client needs and local PV regulations, the exact mix of capabilities and requirements varies.

Whatever your Drug Safety Officer requirements, we can propose and deliver a faster, better, smarter solution to meet them.

Local Literature Screening.

Literature Monitoring specifically at the individual country level is a key part of our Local Pharmacovigilance System at Arriello. Using broad and narrow search strategies and keywords, we search local medical and scientific journals including published study results, literature reviews, meta-analysis, etc.

We can also fully assess all screened information to identify any impacts on patient safety, or anything that may require further investigation or changes in specific markets.

Regulatory Intelligence.

Our faster, better, smarter approach extends right down to the requirements from our local vendors. They provide us with regular updates on changes to local regulatory requirements and legislation by monitoring official sources such as their National Competent Authority, Health Ministry websites and others. Then, all this information is double-checked by another vendor to ensure it is all correct.

This depth of research and monitoring, with a with a double-verification process, means you can be confident that you’re completely compliant in that market. Plus, you’ll gain country-specific insights that could reduce your risk and allow ample forward planning of changes and implementation that can impact your PV system or your product.

Case study: A bespoke cloud based system.
Global Biotechnology, USA

 

This US based Biotechnology company had already chosen Arriello in 2009 to be their partner for outsourcing some of their EU Pharmacovigilance activities, both local and global. The scope covered all local PHV needs - local QP contact, local literature searching, case processing, local regulatory intelligence and support with any ad-hoc regulatory submissions.

Arriello made all these processes faster and better by providing them with one point of contact for vendor management across 14 EU countries.

Local ICSR Management.

We offer complete support for the management of local ICSRs, including but not limited to:

Safety mailbox management
We can monitor, assess, track, process and forward any correspondence and information received in the local safety mailbox.

Local case submission
We can process all local submissions to the National Competent Authorities according to the country specific requirements (e.g. on format, timelines, route of submission, etc.).

Case follow-up
We ensure that all cases that require additional information after initial review are rigorously followed-up back to their sources.

Safety Reports.

Whatever the specific requirement is for writing and developing Safety Reports, you can trust Arriello’s pharmacovigilance experts to gather the right data, use the right formats, and follow the right processes to comply with local regulatory requirements.

Pharmacovigilance Translations to/from Local Languages.

Clear communication is critical for maintaining your MA and protecting lives.
We provide translations specifically for Life Sciences materials across all therapeutic areas. From ICSRs to abstracts and articles from local literature screening, translations are available in virtually any language and at any scale.

Our network is based on a mix of certified translators, or local translators that meet a minimum three criteria of medical background, local language plus English knowledge.

Vendor Vetting and Management.

Our large vendor network includes 128 companies in 92 countries but that doesn’t mean they aren’t subject to the demands of our faster, better, smarter culture.

When you partner with Arriello you can be sure quality extends right through to our vendors thanks to the robust processes our vendor management department has in place for vetting and management including:

Qualification for selection
Using a balanced scorecard, our department assesses and monitors potential vendors based on predefined criteria.

Reporting
We regularly require our vendors to provide reports on their performance, which are then checked internally by our PV project managers and specialists. We also monitor all reporting timelines are adhered to for compliance too.

Compliance monitoring
To ensure our vendors are fully compliant, we conduct on-site and off-site audits based on the frequency identified in the approach to risk planning or Risk Management Plan.

Training
With training, we use education to empower our vendors to follow Arriello’s best practices and our faster, better, smarter approach.

Case study: 23 Countries in 2 months.
Global Consulting Firm, France

 

The client had previously partnered with another consulting firm who lacked the organization and expertise to mange this complex project resulting in a failed initiative. During a previous local PV project, Arriello’s faster, better, smarter approach had previously made impression on this client and they turned to us for support.

Related Pharmacovigilance services.

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.

Download our PV services brochure.

You'll find all the key information about our PV services in our Full PV System and Global PV Network Brochure, which you can download here.

Current or future requirements for a Full Pharmacovigilance solution?

Find out how our faster, better, smarter service can meet and surpass them. Just fill and send the form and we'll be in touch, it's easy.