Local Pharmacovigilance in 50 countries

Global Pharmacovigilance support

Danish Pharmaceutical Company
Est: 1915  Size: 5001 - 10,000 

Arriello 50 Countries Pv Header Image 2

Project: Empowering a Danish pharmaceutical company to outsource its pharmacovigilance activities, providing support through a global pharmacovigilance network spanning 50 countries.
Summary: ICSRs, local literature screening, PV manual and training, regulatory intelligence, safety mailboxes.

Having established its worldwide product in several international markets, this Danish pharmaceutical company was conducting in-house pharmacovigilance (PV) in LATAM, the EU, and Canada - a total of 50 countries. However, after shifting its approach to outsourcing, the organization decided to transfer its PV activities to Arriello. And that meant we needed to provide our client with a Local Contact Person for Pharmacovigilance (LCPPV) in each country, targeted literature screening, localized case processing (ICSR), and regulatory intelligence.

Challenges

Setting up pharmacovigilance (PV) outsource activities for multiple countries usually takes over a year. The problem was, our client faced tight timelines...they needed help, and they needed it fast.

But that wasn’t the only challenge.

A scope of 50 countries meant that clear communication required working around differences such as time, language, culture, ways of doing business, and local regulations.

Collaborating with vendors was also a challenge. Each vendor followed its own system, and we would need to align vendors to a common goal, ensuring compliance and effective management to meet the deadlines.

Solution

Our first step was identifying an LCPPV for each country, screening candidates with a qualification process. After preauditing potential LPPVs, we gave them a questionnaire and evaluated their curriculum vitae. Candidates’ quality management systems, pharmacovigilance systems, experience, and expertise also came under our scrutiny. It was no easy task...especially as we had to repeat this process for 50 different countries. After a kickoff meeting, we introduced the LPPVs to a PV manual we created exclusively for their support and provided training. With detailed chapters on local regulations and requirements, this manual empowered our LPPVs with instructions on what, how, and where to report safety information.

Our client’s local PV system also included literature screening. After preparing a list of periodicals for the drug portfolio, we partnered with vendors who scanned journals in the local languages. If the screening detected new safety information or adverse events, our client would quickly receive a report.

Local ICSR case processing was another way we helped our client mitigate risk. Each country received access to the PV safety mailbox. We then would compile important ICSR findings in a monthly report for our client to follow up on.

But our local PV services would not have been complete without regulatory intelligence once the project went live. Our vendors compiled information for a monthly report to keep our client up to date. If the information was urgent, our vendor would alert our client within one business day.

Faster. Better. Smarter.

By the end of the project, we complied with our client’s requirements and delivered a comprehensive local PV service in nine months...when it should have taken over a year.

And, despite the urgent deadlines, our client realized full implementation without encountering major obstacles. Extensive collaboration with vendors and our PV manual and training empowered our client to avoid pitfalls and experience a smooth process.

By the end of our project, the Danish pharmaceutical company had established a local PV network for 50 countries. But, most importantly, the organization had achieved its goals faster, better, and smarter.

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