In this blog of the ‘Career Insights’ series we talk to Alessandra Marchese, Drug Safety Manager of seQure, to find out more about her career path, achievements, current role at seQure, and her interests outside of work.

Alessandra Marchese Drug Safety ManagerHow did you choose pharmacovigilance as your future career?

I hold a Master’s Degree in Medical Biotechnology. During my studies, I started to take interest in pharmacovigilance – I was very impressed by the positive impact it has on the life of patients. I have chosen it as my career because I wanted to be part of the process that helps to make medicinal products safer for patients.

You have been in seQure for almost 2 years – how has your journey been so far?

Very gratifying! I get a chance not only to apply the skills that I already have but also to acquire new ones thanks to mentoring from more senior colleagues. I also feel like my knowledge makes difference and benefits our clients. This is the constant source of my motivation!

As Drug Safety Manager, with who in the team do you collaborate closely?

My work is to guarantee the quality delivery of our clients’ projects and adherence to deadlines. Together with my colleagues from the pharmacovigilance team, I ensure that the activities are carried out correctly and contribute to our clients’ success.

I closely work with the Director of Pharmacovigilance and Managing Director of seQure and also with our Business Development team. This synergy allows us to offer to our clients only the most tailored, lean, and high-quality solutions.

What do you think are the biggest challenges pharmacovigilance faces at the moment?

I believe that the biggest challenges in pharmacovigilance related to finding the fragile balance between risks and benefits of the medicinal product.

In recent years, pharmacovigilance is being involved in the implementation of solid and concrete processes of signal management with the use of the EVDAS tool.  This is done with the aim of monitoring the risk-benefit profile of medicinal products and minimising the risk of harming the patient.

The monitoring of both the safety and efficacy of medicinal products, also during clinical trials, is a priority for pharmacovigilance because the drug development is based on a fair balance between efficacy and safety.

Another big challenge for pharmacovigilance is related to the adoption of adequate ways for spontaneous reporting of adverse drug reactions and appropriate coding and analysis of case reports. These activities are crucial – both misreporting and miscoding of adverse reactions may lead to incorrect data analysis and unrealistic signals.

Which current pharmacovigilance trend are you excited the most about?

Currently, I am closely watching these two trends that play a key role in improving the drugs’ efficacy and the patients’ health:

  • Identification of benefits and risks of drugs in order to monitor their safety and efficacy on the market
  • Promotion of the safe use of drugs with effective communication among patients and the public health

What do you think are the main advantages of pharmacovigilance outsourcing for pharmaceutical companies?

  • Pharmaceutical companies can benefit from expert pharmacovigilance support on demand. This allows them to lower resources and infrastructure costs and increase flexibility and efficiency.
  • Outsourcing in pharmacovigilance also gives access to highly qualified and trained pharmacovigilance team which might be challenging to create internally

What are the three main skills that a Drug Safety Manager must have?

  • Time management – vital for setting manageable goals for the team and for respecting the planned timelines
  • Problem-solving – a Drug Safety Manager should always be ready to brainstorm on solutions if a problem arises. The right approach will help to mitigate the risks that can endanger the project delivery.
  • Communication – a way to build trust and a positive team environment

What do you like to do in your free time?

I love traveling and during the winter I usually spend weekends in the mountain or on the lake-side – during my stay in Milan, I have visited so many beautiful places in the North of Italy.

I used to spend my Saturday afternoons going to the exhibitions and museums with my friends, and I hope that soon it will be possible again – I miss these afternoons so much!

Also, I love swimming, especially after an intense day at work. I believe that finding time for yourself even during the week is very important, in order to have the energy to face another day of work.

In the times of the pandemic, I am mostly spending reading books and catching up online with my family and friends.

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