Risk management and compliance
in 143 countries around the world.

Take the smarter approach and discover how we can provide a comprehensive local PV solution through our Global vendor network.

Arriello Global Pv Network 2019 2

Arriello’s Global Pharmacovigilance (PV) Network and services.

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 serious repercussions for you, and for patient safety.

It’s an undeniable fact; an ineffective local PV service 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 local PV system is critical.

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 global network of external PV vendors currently spans 128 companies in 92 countries, enabling us to offer a completely tailored Local PV service.

We can offer a completely tailored Local PV service solution to your requirements based on the following areas:

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

Drug Safety Officer.

A major and growing role in Pharmacovigilance is that of the DSO – Drug Safety Officer. This role is often connected/interchangeable with the titles LSO - Local Safety Officer, LRPV - Local person Responsible for Pharmacovigilance 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.

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.

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

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 make sure we’ve fully assessed any available information that may have an impact on patient safety, or require further investigation or changes required 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 all it is correct.

This depth of research and monitoring, with a double-checking 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.

How do we operate in 143 countries?

We have a highly trained and knowledgeable network of local specialists that meet our faster, better, smarter standards, and can respond to sometimes frequent changes in local legislation.

Arriello's Head of Global PV Network and services, Zuzana Plánočková, talks about how our rigorous auditing program makes sure we deliver for our clients, on time, every time.

 

"“Although the PV principles remain the same, every regulatory authority and every company can have a different interpretation of PV requirements and PV legislation.

With the depth of expertise we have at Arriello, and the quality of our extensive global network, we can and do meet all the local PV requirements of regulators, and our clients, faster, better, smarter.”

Arriello's Global PV Network - Zuzana Plánočková

Zuzana Plánočková
Head, Global PV Network and services

Arriello has highly knowledgeable staff in all countries with a very professional attitude. They are very fast in responding when needed.

Berit Lindholm
CEO, Bluefish Pharmaceuticals, Sweden

Case Management at the local level.

We offer complete support in management of ICSRs on local level, 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.

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.

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.

Risk Minimization activities.

At Arriello, we provide support several risk minimization activities targeted at increasing patient safety close to the source.

These can include documents that may help physicians properly prescribe your drug or patients and doctors to properly use it (e.g. Direct Healthcare Professional Communication (DHPC), educational materials and other communications) – all according to the guidelines and requirements of the national competent authorities in that location.

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.

Full Pharmacovigilance System and services.

We also offer a Full Pharmacovigilance System and services. These have been developed and refined over several years and are 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. For more information, click here.

Current or future requirements for nationally targeted Pharmacovigilance solutions?

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.