Local Person for Pharmacovigilance.
Local Safety Officer.
Expert pharmacovigilance, wherever you need it.
Local Person for Pharmacovigilance (LPPV).
We know and understand the PV requirements in each market around the world, and through that extensive experience, how that matches your local PV expectations.
We can do this through our network of international partners which is qualified and audited by our vendor management team, operating under our Quality Management System, and allows us to keep high degree of control and compliance monitoring.
We can provide either a Local Person for Pharmacovigilance (LPPV) service, or a Local Contact Person for Pharmacovigilance (LCPPV) service, where this is legally required.
Local Safety Officer.
Where an LPPV is not legally required, we can provide the services of a Local Safety Officer (LSO), a growing role in PV.
The LSO role’s objective is primarily the same as an LPPV’s, regardless of the title – to have a dedicated, knowledgeable, and efficient technical service at the individual country/ territory level.
As the role is flexible depending on individual client needs and local PV regulations, the exact mix of capabilities and requirements can vary, but whatever your LSO requirements, we can propose and deliver a faster, better, smarter solution to meet them.
Arriello offers a unique blend of in-house resource and expertise, combined with local in-country staff who fully understand local regulations. This includes but is not limited to:
- ICSR intake and local level processing.
- Local submissions (aggregate reports, RMPs, ICSRs, etc.).
- Compliance monitoring.
- The implementation of aRMM.
- Fulfilling local PV requirements in relevant procedures and systems.
- Providing PV/product-specific training.
- Health Authority inspections.
What our clients say about us.
Working with the Arriello Clinical Safety Team has resulted in flawless forethought, planning and execution. Their global regulatory expertise, coupled with their quality acumen, sets a standard for which other PV service providers should aspire. Nothing has fallen through the cracks and I can sleep at night knowing we are not only operationally prepared, but inspection-ready – a comfort for which I would happily pay multiples.
You already had in place all the SOPs and processes needed for a PV system, but in our case, you were always open to work with parts of our system (some of our internal SOPs...) including some really special Cinfa requirements.
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.