In this interview, we talk with Stefania De Santis, Director of Pharmacovigilance of seQure, the business unit of Arithmos, to find out more on her job, career path, achievements, and hobbies.
Can you give us an insight into your work in seQure, the business unit of Arithmos?
My day is divided between work supervision, operative activities, and mentoring.
As Director of Pharmacovigilance I am responsible for supervision of all the pharmacovigilance activities, including management of the team and resources, quality delivery of projects and adhering to deadlines.
I am also involved in operational activities that require senior expertise such as signal detection and medical writing including preparation of periodic safety reports and risk management plans. Moreover, I cover the role of QPPV for some clients – it is a role that entails personal legal responsibility and requires 360-degree knowledge of all pharmacovigilance processes.
In seQure we have not only seasoned professionals, but also young pharmacovigilance specialists and it gives me great satisfaction to mentor them. I dedicate a lot of my time to guiding them, sharing my experiences and assisting them to make the right decisions. Pharmacovigilance is very unpredictable and making the right decision is sometimes challenging. I am always on hand for the final revision and assessment, particularly in cases when extensive scientific competence is required.
What does your day typically look like?
I start with checking my emails and dealing with urgent questions. Then come client-related tasks, for example working together with our Sales department on the proposals. I am happy to be involved in it, because in this way we prepare tailored proposals with the highest value for our clients.
Part of my day is dedicated to operational work, and of course, there is space for the social moments! A morning coffee with the team helps to set the mood for the workday and create warm atmosphere.
Have you been always passionate about Life Sciences and pharmacy?
When I was a kid, I wanted to study biology and botany. I enrolled the university to become a biologist. However, my father was working in pharmaceutical industry, so I grew up hearing him talk about it. I guess this is why in the end I decided to work in this industry.
What was your journey to your current position in seQure, the business unit of Arithmos?
I started working in the medical marketing department of a pharmaceutical company, and during my work I was also keeping my eyes peeled for any report of adverse reactions from the field. Then, the Italian decree DPR 93 of 25 January 1991 was introduced and pharmaceutical companies had to establish a pharmacovigilance service and appoint a responsible person. My company assigned this task to me – this is how I started working full-time in pharmacovigilance.
I have worked in a big pharma for 30 years. At some point I have thought – “why not to see other sides of the industry?” – and decided to move to consultancy. This is how I joined seQure, where I have learnt how pharmacovigilance processes can be managed by vendors.
What career achievement you are most proud of?
I had numerous experiences building a pharmacovigilance team from scratch, and this is often challenging, but a very rewarding task. For me a team is more than a group of people who work together – its people who share passion for pharmacovigilance, who survive ups and downs together, and strive to do their best.
What most inspires you about working in pharmacovigilance?
First, it’s the regulatory environment. Understanding the rules, clarifying them, applying them in the most effective way that will benefit the patient.
Secondly, the fact that as pharmacovigilance professional, I contribute to safeguarding of the health of the patients. Pharmacovigilance ensures that a medical product benefits the patient with minimum side effects and improves their lives. This motivates me a lot.
What would be your top tips for early career specialists looking to develop in pharmacovigilance?
- Get diverse business experience – give yourself an opportunity to join either a pharmaceutical or a consultancy company, or both. This will allow you to understand how different stakeholders work.
- Be humble. Even though certain tasks may seem too easy for you, they will allow you to acquire new competencies and knowledge. Never think that you are too experienced to do something.
What are your personal values?
Dedication to everything I do. I do my work the best I can, because I want to deliver the best quality to my clients and also because it gives me personal satisfaction.
What do you love to do for fun?
I love yoga and I do it at least once a week. I also sing in a choir, and what fascinates me about it is the end result – you have a lot of people, each of them has only one voice. However, when put them together, these voices create a beautiful song.
I also kept my passion for botany. I often take a walk in the countryside and look for interesting species. Of course, I have a bunch of plants at home, and I am even a counsellor for the local city garden!
About Stefania De Santis
Director of Pharmacovigilance of seQure, the business unit of Arithmos
Stefania De Santis is a qualified EU QPPV and is seQure’s Director of Pharmacovigilance; as such she is responsible for strategic planning and workflow development as well as guaranteeing the quality of our pharmacovigilance services.
Stefania has more than 30 years of experience in the pharmaceutical sector where she has been involved in various departments, but mainly in Pharmacovigilance, throughout her career. Before joining seQure, she was dedicated to the field of pharmacovigilance as Head of Corporate Drug Safety and qualified Deputy EU QPPV for a major pharmaceutical company since 1992.
Stefania has extensive experience in all pharmacovigilance operations, in both pre-registration and post-marketing settings, case processing, PSUR and DSUR preparation, ICSR/SUSAR management and electronic transmission to the EMA, signal detection and management, safety database validation, safety variations, RMPs development, SDEA/Safety Management Plans and liaising with regulatory authorities.
She is certified by the EMA for the use of Eudravigilance and EXVMPD (Medicinal Product Dictionary).
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