Meet the TEAM

Meet the Team: Sam Tomlinson
Vice President of Global Drug Safety.

Sam Tomlinson
Sam Tomlinson
Vice President of Global Drug Safety

Sam has over 20 years strategic and operational experience in global Pharmacovigilance in both large pharma and small to medium sized pharma organizations.

Sam also has experience as an EU QPPV and her expertise spans across the product lifecycle from clinical trials, through post marketing and product discontinuation.

Additionally, she has managed and supported numerous Health Authority inspections including EMA, FDA, MHRA, ANSM, Health Canada, HPRA, and AIFA.

What is a typical day like for you, as the Vice President of Global Drug Safety?

Being honest there is no such thing as a typical day but there is one over riding theme which would be developing strategy, be it for client projects or department processes and procedures. To give you an example yesterday I began the day discussing options for the internal use of AI, automation and database utilization, from there I went to a client call where I was helping them develop their pharmacovigilance system as they move through approval and commercialization and I closed out the day supporting a QPPV with the implementation strategy of the local PSMF.

I work very closely with my colleagues in Q&C and regulatory affairs to provide holistic consultancy for companies planning commercialization in Europe and due diligence / merger and acquisition compliance reviews. In relation to the management of the wider PV team, it is very diverse, both in terms of the services we offer and the skill sets we have in house. This means as the Head of Department I am able to provide a unique consultancy offering for our clients as opposed to more traditional transactional services.

Within PV our safety data management team not only support our case processing activities but will guide our clients on best practice for the management of complex data sets. Our physicians specialize not only in case review and the provision of signal detection services but supporting our clients in the development of benefit: risk assessment procedures. For our clients who are in the clinical phase we have specialists in the administration of all aspects of clinical safety as well as expertise in supporting patients as they roll off the study such as Expanded Access Programs (EAPs) and compassionate use. Finally (maybe last but definitely not least!) we have a truly international team of regional and local QPPVs who not only understand the regulations they work within but also understand that when it comes to implementation each client will need a unique solution tailored to their organization. This unique mix of skills means that we really can guide organizations through the tricky regulatory landscape from early phase clinical to post authorization.

What do you like best about collaborating with clients?

I love working with our clients and learning about their products and organizations. PV is always challenging and almost every situation requires a unique solution so being able to help and support them is very satisfying. Additionally, here at Arriello, for all of the reasons I have just mentioned many of the projects we work on grow into long term partnerships, so it really becomes a close collaboration and it’s wonderful to be part of the journey as their business grows.

Are you noticing any trends in issues/pain points from clients, and can you share any recommendations from this?

There are many but the big one I would say is technology which is both a benefit and a challenge in PV today, it brings huge advantages in terms of consistency and efficiency but at the same time brings challenges in terms of data security and oversight. Additionally, the number of potential sources of safety data that PV teams now must contend with is mind blowing. Whilst technology platforms can really enhance reporting, they can also massively increase the number of reports received, while we absolutely encourage this it requires resource and innovation to ensure it is managed appropriately and compliantly.

What is unique about working for Arriello?

I think Arriello is very special place to work, the Senior Leadership Team are huge advocates of innovation but even more importantly really care about the client experience. Our client portfolio is also exceptionally diverse, so we get to support products and technologies that are cutting edge and changing patients’ lives.

The PV team are a truly dedicated group of safety professionals who, without exception, want to go the extra mile to support our clients. Many of them (like myself) have come from working inside pharma companies and have been at the coal face so we really understand what it is like to stand in the client’s shoes. I had some feedback from a client recently who said that the reason they worked with Arriello was because we don’t just think about the transactional service and the here and now, we are always thinking a step ahead and the upstream impact of any work that we do. That really for me, summed up a large part of the Arriello USP. (editors note: Unique Selling Proposition)