Team Tuesdays: My role as an ADAMAS GVP Consultant Auditor

by | Mar 3, 2020 | ADAMAS Team Tuesdays

My situation when I applied to ADAMAS
When I applied to ADAMAS I was working for a large Clinical Research Organization (CRO) as their sole internal Good Pharmacovigilance Practice (GVP) Auditor, having been initially engaged to set up the internal GVP audit programme. I was responsible for the delivery of the internal GVP audit program, which typically included global process audits of the CRO’s pre- and post-marketing PV service offerings. I often led teams of between one and three Good Clinical Practice auditors who were interested in learning more about GVP. The audits were conducted against international legislation and guidance. I also conducted audits of vendors supporting the PV function.
My motivation for joining ADAMAS was to join a team of dedicated GVP auditors in order to gain further expertise, exchange knowledge and audit a greater variety of organizations to consolidate my skills and knowledge base.
Previous interactions with GVP Consultants and my perspective before joining
Prior to my application to join ADAMAS I had some interactions with independent GVP consultants who typically had a background working in PV for many decades and had varying specialties and experience ranging from operational, inspectorate and quality, so I was not sure whether I would be successful in an application to join an auditing consultancy.
ADAMAS Application process
I applied via an agency to the position of a GVP Consultant at ADAMAS. The Agency had found my details on LinkedIn and approached me. My CV was provided to the Head of GVP Practice and we had a short telephone discussion to review my experience, my motivation for joining ADAMAS and my longer-term goals. I was offered a face-to face meeting at the ADAMAS headquarters shortly afterwards.
The face-to-face interview was a little daunting (as all interviews are), and was divided into three sections: a verbal interview with the Head of GVP Practice; followed by a short assessment to test my knowledge, core skills and performance under pressure; and finally a discussion with the Chief Executive Officer.
I came away from the interview feeling anxious about the result but certain that I would accept the position if it was offered. I received a call a few days later to notify me that my application was successful. I was very excited and accepted the offer immediately!
Induction & Training
My induction was performed onsite at the ADAMAS headquarters in Berkshire. I met key operational staff, Finance, Administration and Information Technology, and received inductions from each in the relevant departments on their processes, before I was introduced to the Quality Management System and started my procedural training.
The Head of GVP Practice explained my role and responsibilities, our team structure, and my on-the-job training program which would get me up to speed with the ADAMAS GVP audit process. I was assigned to three audits where an experienced ADAMAS GVP auditor provided mentoring and assessed my skills throughout the audit and provided feedback where necessary to refine my skills.
Acclimatizing to working directly with clients, rather than internal stakeholders, was challenging but also very rewarding because I feel like I make a difference.
Benefits of working at ADAMAS
I joined ADAMAS in April 2016 and throughout this time one of my favorite parts of working for ADAMAS is the people I work with. My team members come from a variety of different backgrounds, from industry, EU-QPPVs, and ex-inspectors. We are truly an international team with nationalities that include Dutch, Irish, Spanish, American, Indian, Czech, Turkish and British. We have a global perspective due to shared audit experiences which are discussed during regular meetings and informal catchups.
In terms of support while auditing, even though most of our audits are conducted by a single auditor, someone is always available to answer questions and to “bounce ideas off” due to the rotational nature of the audit scheduling.
I also like the autonomous nature of the work, the far-flung travel destinations, the work-life balance and being entirely responsible for the delivery of my assigned audits.
The type and scope of the audits varies greatly so there is something new to experience and this provides much opportunity to learn new skills and consolidate previous knowledge and expertise. Since joining I have conducted audits of Business Partners, PV Service Providers, Affiliates, Distributors, global processes and niche service providers such as translation vendors, patient support programs and market research organizations. Also, the audits are not limited in terms of geography and in the past four years at ADAMAS I have audited as far afield as Argentina, South Africa, Australia, USA and Japan.
To find out more about what I do at ADAMAS, or the company itself, feel free to email me or visit www.adamasconsulting.com.

Sarina Norris

Senior GVP Consultant
ADAMAS Consulting
sarina.norris@adamasconsulting.com

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