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.