Leaders and Key Contacts.
Faster, better, smarter starts at the top… and keeps going!
#TeamYellow leverages strategic acumen, pharmaceutical expertise, and intercultural proficiency to make your vision a reality.
Below you’ll find information about our key management and technical team members.
Arriello’s founders & directors.
Alan's role is to lead the organization with the drive and energy required to continue to make the company a success. He has a close connection to the Commercial activities of the company, working closely with the Commercial Operations Director and Chief Marketing Officer.
Alan has worked in the Pharmaceutical space since 2005 but also has commercial experience in the IT, architectural and lighting sectors. It is this broad range of experiences that gives Alan a different perspective on the industry he works in.
Common to all these areas is his ability to problem solve and take a common-sense approach to situations. He has a close affiliation with clients – a people’s person.
Anna oversees our Pharmacovigilance, Regulatory and Project Management teams, balancing keeping our clients super happy whilst developing and nurturing our growing team.
She has worked in the pharmaceutical industry since 2005 in the business development and operational areas.
Anna acquired her customer centric approach from the hospitality sector where she received extensive training and experience after graduating from university in the US.
She is a strong believer in leading by example and would not expect anyone to do something she was not prepared to do herself.
Michael has been with the organization since 2011 and is currently responsible for ensuring that the group remains compliant in all contractual aspects.
He is a Chartered Accountant with a wealth of experience in contract management as well as accounting and taxation.
He graduated from EY with an FCA in Accounting.
Michael is the Intragroup Finance Director at Arriello, based at our headquarters in Dublin, Ireland.
Pharmacovigilance Team Leaders.
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.
Sonia has 20 years of experience in global and local Pharmacovigilance in both large pharma and service provider organizations.
She has worked in a range of roles in the QPPV Office team, Clinical Safety, RSI management, Local Safety Officer support, QPPV Office support and Quality and Compliance management.
Her service provider experience includes extensive people management alongside project delivery, focused on compliance and consulting solutions.
Regulatory Team Leaders.
Pete has over 24 years of experience working across the Pharmaceutical, CRO and Consulting Industries.
Grounded in UK and European regulatory activities, and in particular, developing and executing strategies for generic and early-stage development programs, his responsibilities have included, but not limited to; Agency Scientific Advice, feasibility of accelerated tools such as EMA-PRIME, MHRA-ILAP, CMC, PIP, Market-Access and MAA due-diligence.
More recently, Pete has supported US IND/EU CTA and Chinese IND submissions, leading a team for the development and execution of Early (& Post-Trial) Access Programs.
Jayne has over 30 years strategic & operational Regulatory Affairs expertise in pre & post marketing across the EU, UK, US, and other territories.
She has experience in multiple areas including ATMPs, biologics, small molecules, marketing authorizations and pre-marketing development activities.
This includes supporting interactions and meetings with regulatory agencies in Europe (National and EMA) as well as with the FDA & Health Canada.
Jayne holds a PhD in Biochemistry from the University of London.
Sandra holds a chemistry degree and has 20 years of pharmaceutical industry and consultancy experience. She started her work as a Scientific Investigator in the wine industry, and moved into pharmaceutical development, interacting, and contributing at the earliest stage of the medicinal lifecycle.
In 2007 she moved into regulatory affairs and has submitted over 500 new MAs in the EU with national and European procedures, which included CMC (Chemistry, Manufacturing and Control) construction, LoDs preparation and revision and the consequent lifecycle maintenance of those products after approval.
Auditing Team Leaders.
Kate has over 20 years’ experience in Quality Assurance, Sterility Assurance, Microbiology and Quality Control, and has worked across ATMPs, Biologics, Sterile Fill Finish, Vaccines, APIs and Oral Dose platforms.
Over her career to date, Kate has served as a practicing QP, Principal Consultant, and qualified Lead Auditor. She is also a subject matter expert in Commercialization readiness, Supply Chain GDP, MAH Compliance, Quality Risk Management, New Facility Design/Start Up, Quality Control and Sterility Assurance. In her previous role before joining Arriello, she was Senior Director for Quality Management and Compliance, and Head of QMC for Ireland and UK.
Kate is particularly passionate about the management of risk and the interdependence of Regulatory and Quality, as companies develop their strategies and processes and look more holistically at what they need, rather than operating in silos.
Kamila is the Quality Audit Lead at Arriello and is an ISO 9001:2015 certified Lead Auditor.
An enthusiastic GVP QA professional, she has an in-depth knowledge of GVP requirements and legislation, and extensive experience in implementing and managing PV Quality Management System processes, including PV QA auditing with Local PV Service Providers globally and Full PV System audits.
She also has experience with vendor qualification and management, PSMF maintenance, validation activities, and she is responsible for preparing CAPA plans and managing the CAPA process within Arriello.
Monika, a PhD candidate in clinical pharmacy and a pharmacist by training, is an Arriello auditor – part of our Auditing and QA independent services team.
A former EU Senior GVP Inspector, GCP Inspector (in training), she has extensive proficiency of these GXP requirements and legislation in the field of pharmacovigilance. Participating in more than 30 inspections, as a member of PV inspector's working group and while participating in the EMA international inspection team, Monika has gained broad PV expertise.
In addition to GVP inspection training, she has received EMA training on the mandatory use of the ISO/ICH E2B (R3) ICSR standard in the EU, and is fully trained in MedDRA.
Our pharmacovigilance advisory board.
Based evenly across the US and Europe, each of our board members commands a unique high-level industry insight, having worked with or for the EMA, FDA, MHRA, ICH, CIOMS and many other key organizations on national and global projects and initiatives.
Dr. John Price is an executive physician with deep experience gained from over 25 years working across the breadth of regulatory affairs and pharmacovigilance worldwide.
He has created and led high-functioning global departments for pharmacovigilance, regulatory and clinical operations, medical writing and drug development, and held senior roles in the UK Medicines Control Agency (now MHRA), Pfizer, J&J, Alexion Pharmaceuticals, and academia.
Dr. Judith M. Sills, Pharm.D. is President of JM Sills Consulting LLC, specializing in pharmacovigilance and benefit-risk management.
Dr. Sills has over 30 years of experience in pharmacovigilance in the pharmaceutical industry, FDA, and consulting.
Prior to establishing a consulting practice in 2018, she was Vice President and Head, Global Pharmacovigilance at The Medicines Company.
Dr. Panos Tsintis has a total of over 30 years of pharmacovigilance, regulatory affairs and pharmaceutical medicine experience, from drug development to post-marketing.
Between 2002 and 2008 he was Head of Pharmacovigilance and Post-Authorisation Safety and Efficacy Sector at the European Medicines Agency (EMA).
He has also held senior positions at the UK MHRA as well as in the pharmaceutical industry.
Dr. Eric Caugant has over 25 years of experience in Pharmacovigilance, Drug Safety, Risk Management, and more broadly Pharmaceutical Medicine.
In 2017, he founded Pharmacovigilance Systems Consulting (PhVSC).
Prior to this Eric held senior positions, in various pharmaceutical and biotech companies, such as Alexion, Bayer Lilly, Wyeth and also the French Ministry of Health.
Our regulatory advisory board.
Dr. Howard Levy, Peter Kennerly and Dr. John Price form Arriello’s founding regulatory advisory board, with a wealth of experience and knowledge to help define the future of our regulatory affairs services.
As with our PV advisory board, they bring their unique perspectives from both the US and Europe in clinical and post-marketing scenarios for biotechs and large pharma. They also bring their insights from direct experience with the EMA, FDA and many other key industry bodies.
Dr. Howard Levy, M.B. BCh., Ph.D., M.M.M. has over 20 years of experience in Clinical Development, Medical and Regulatory Affairs in the pharmaceutical industry and has been Chief Medical Officer at 4 Biotechnology companies, and has consulted for numerous biotechnology start-up companies.
He has been involved in the development of 6 approved agents in the USA and Europe.
He is currently Chief Medical Officer at Ampio Pharmaceuticals and maintains a robust consulting practice.
Dr. Peter Kennerley, Mb ChB, DA (UK), DPM, FFPM, MTOPRA has over 35 years’ experience in drug development and product safety oversight. He is a former Senior Medical Assessor for the UK Regulatory Agency with extensive experience in negotiations with European national regulatory authorities as well as the European Medicines Agency and experience in safety negotiations with the FDA.
He has worked in small and large pharma, establishing global drug safety processes with oversight of multiple successful regulatory procedures for rare and orphan products. He is an experienced chairman of Data Monitoring Committees, expert panels and a published medical scientist.
Dr. John Price is an executive physician with deep experience gained from over 25 years working across the breadth of regulatory affairs and pharmacovigilance worldwide.
He has created and led high-functioning global departments for pharmacovigilance, regulatory and clinical operations, medical writing and drug development, and held senior roles in the UK Medicines Control Agency (now MHRA), Pfizer, J&J, Alexion Pharmaceuticals, and academia.
