In this blog of ‘Career Insights’ series we talk to Nicola Sisti, Drug Safety Manager of seQure, to find out more on his career path, achievements, current role at seQure and his interests outside of work.

Can you give us a little background on your career and your journey so far?

I hold a Master’s degree in Pharmacy from Università degli Studi di Perugia (Perugia, Italy). After its completion, I have continued my post-graduate training with a Master’s programme at SDA Bocconi School of Management where I specialised in Healthcare Management. I worked in pharmaceutical, biopharmaceutical, and biomedical companies in different departments such as pharmacoeconomics, product and project management.

I have joined seQure in November 2015 as Pharmacovigilance Officer and in 2017 I was promoted to Drug Safety Manager and then Case Management Coordinator. Currently I am responsible for post-marketing case processing of specific projects and starting from the last months I am involved in the auditing activities as GxP consultant. I am also an invited speaker at specialised workshops for students of Master of Science programme and fellow professionals in pharmacovigilance.

Nicola Sisti Drug Safety ManagerWhat does your day at seQure typically look like?

As Drug Safety Manager I am in charge of managing crucial aspects of our work such as quality control, production of safety reports, reporting ICSRs to Competent Authorities, writing and review the project’s related documentation of post marketing and clinical studies case processing.

My other daily activities include analysis and submission of safety reports in EudraVigilance, MedDRA coding, monitoring of the scientific literature and of the Competent Authorities sources for safety information, drafting of Standard Operating Procedure (SOP) – Working Instruction (WI) and support of periodic aggregate reporting.

Finally, I also do a lot of mentoring in seQure. In seQure we believe in helping our colleagues grow and thrive and mentoring is an essential part of this process. As a mentor, I help our junior colleagues learn the ropes at a company and support them during the day with pharmacovigilance and safety database activities.

My favourite part of the workday is late afternoon when all tasks are completed and I focus on planning out my activities for the next day.

What most inspires you about working in pharmacovigilance?

Pharmacovigilance is a real tool to safeguard public health. I am proud to be part of it and to promote the safe and effective use of medicines, in particular by providing timely information on the safety and to improve drug prescription and regulation.

How do you see pharmacovigilance changing in the future?

Pharmacovigilance systems are changing significantly due to technology advancements and increasing volumes of data available to regulators and companies. For this reason, smart collection and reporting of suspected adverse reactions safety reports, and active interaction between regulators, patients and healthcare professionals will be key elements of pharmacovigilance in the next years.

What according to you are some new skills aspiring pharmacovigilance professionals should acquire?

I would suggest these two skills:

  • Interpersonal relationships skills especially where it comes to communication, negotiation, and management of difficulties
  • Ability to work in multidisciplinary management teams and learn from others – not only members of their own pharmacovigilance team, but also other professionals from other fields such as QA

What are your personal values?

Passion, honesty, accuracy. These are the values I live by and they define my way of working, communicating with my colleagues and supporting our customers’ projects.

Nicola Sisti Drug Safety ManagerWhat do you love to do in your spare time?

I am a huge fan of classical and modern art and music, in particular rock music. That is why one of my favourite pastimes is going to see exhibitions and museum and listen to concerts. I also love to travel and visit non-touristy places and villages.

seQure careers

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