In this blog of ‘Career Insights’ series we talk to Maria Marchionni, Safety Physician of seQure, to find out more on her career path, achievements, current role at seQure and her interests outside of work.
Why did you decide to pursue a career in pharmacovigilance?
While I was following Gastroenterology course at La Sapienza University in Rome, I became passionate about the methodology of clinical trials. I was so interested in it that I decided to move to the pharmaceutical sector in clinical research and start my career there. Since then I have covered various roles in the areas of Medical Affairs, Clinical Safety and Pharmacovigilance in different pharmaceutical companies, including the roles of Drug Safety Physician and Pharmacovigilance Manager in local affiliates of big pharmaceutical companies. I decided to focus on pharmacovigilance and safety because of my interest for this new discipline. I like how dynamic it is!
How has your medical training prepared you for your current role as a Safety Physician?
A medical background is an advantage as it helps to understand clinical cases, since safety data received in paper or electronic forms are very similar to the data collected by a physician from a patient and reported on a standard hospital case record form.
What is more, my background helps me to understand actions taken, event outcome and causality of the drugs administered in determining or concurring to the occurrence of a certain event with a certain drug.
As a physician, I also see the patient behind a SAE form and have advanced insights into each case.
What does your day typically look like?
Firstly, I check my e-mails and phone messages to see if there are any updates from clients, investigators, stakeholders. Then I make a priority list for my workday. Planning and Project Management are essential for my job.
Then I start working on my tasks. These can be both operative and project management tasks – as a senior professional with experience in management of local pharmacovigilance systems and clinical studies, I do a lot of coordination work for complex pharmacovigilance projects.
Among my most important operative tasks are the medical review and the final assessment of the case and medical writing of part of key regulatory documents, such as PSUR reporting (Periodic Safety Update Reports), RMP (Risk Management Plans), and ACO (Addendum to Clinical Overview).
What most inspires you about working in pharmacovigilance?
For me as a person with a medical background, patient-centricity in pharmacovigilance is one of my main motivations. I also enjoy the fact that pharmacovigilance combines several different disciplines into medical science that is so challenging and dynamic.
What would be your top tips for early-career specialists looking to develop in pharmacovigilance?
Here is my top four tips:
- Engage in project with different stakeholders, different businesses, and different therapeutic areas. Also, different cultures! This will help you to handle different and unexpected situations.
- Dedicate yourself to your tasks with all your heart, otherwise you will not have a clear understanding of the process with all its unexpected pitfalls and issues….and then you can’t really master it.
- Never stop learning, you can learn from everybody around you, both senior and junior colleagues.
- Be a real team player – in pharmacovigilance knowledge is shared, since management of the cases is a multi-step and highly integrated process.
What are your personal values?
As a person trained as physician, I have dedication and a strong feeling of responsibility towards patients. These feelings also define my approach to all Safety and Pharmacovigilance tasks.
What do you love to do in your spare time?
My passions are art and history, architecture and interior design. For me, they are tangible expressions of the human vision of life and its evolution.
I also love discovering new facts about local history, as it is a way of connecting the past with the present. Last, but not the least – food and wine! In Italy, it is part of the exploration of the country.
Do you want to become part of seQure team? We are a dynamic company and we are constantly looking for new talents for our team. Check our current job openings and apply!