5 Questions w/ Leonardo Giraudo, Veterinary Pharmacovigilance & Compliance Expert, PQE Group
Learn more about Leonardo Giraudo, as he highlights his journey from earning a degree in Chemistry and Pharmaceutical Technologies in Italy to becoming a pharmacovigilance and compliance expert at PQE Group, specializing in veterinary medicine.
November 20, 2024
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1) Please introduce yourself to our audience by looking back at your education, training, and career path.
I’m Leonardo Giraudo. I graduated from the University of Turin (Italy) with a degree in Chemistry and Pharmaceutical Technologies. Subsequently, I obtained a post-graduate master’s degree in Product and Process Management at the Turin School of Management. Following graduation, I worked with pharmaceutical companies for more than eight years, taking on different roles in Quality, Regulatory, and Pharmacovigilance, including leading the compliance unit of an Italian Veterinary company operating in medicinal and feed businesses. Currently, I am working at PQE Group as a pharmacovigilance and compliance expert for veterinary companies and supporting the team for the veterinary field.
2) Can you share more about your specific role at PQE Group? What are your main goals in this role, and what’s your favorite part about your job?
As a pharmacovigilance and compliance expert for veterinary companies at PQE Group, supporting the business development team for the veterinary field, the primary activities that I execute are in support of pharma companies that need to review their pharmacovigilance system organization and documentation in order to be compliant with the applicable regulations. In detail, we review and write a Pharmacovigilance System Master File (PSMF), a Detailed Description of the Pharmacovigilance System (DDPS), Standard Operating Procedures (SOPs), policies, and quality documentation in general, as part of clients’ pharmacovigilance (PV) systems. I also perform all the main PV tasks and cover critical PV roles such as Qualified Person Responsible for Pharmacovigilance (QPPV).
I also support the Regulatory Affairs team with Veterinary clients in projects focused on dossier review and writing, GAP assessment,s and other regulatory procedures. I also perform projects on Veterinary Medicinal Devices and Feed products.
3) Can you tell us more about why companies should consider partnering with PQE Group and what type of services you offer to your clients?
In the last two years, PQE Group has developed the specific knowledge required to support veterinary companies in their growth paths. We can support these companies, beginning with drug development, by writing the dossier’s compliance portion with the applicable regulations and performing all the activities requested for the maintenance and update of the existing dossiers. We support our clients by providing our regulatory strategic plans to enable them to evaluate every possible scenario in terms of regulatory and quality requirements, as well as budgets needed for the activities requested. We can support customers with their pharmacovigilance system by developing new systems, updating existing ones, or providing a complete outsourcing capability with our internal Veterinary PV system. We are also able to support clients with specific PV roles such as responsible person, PV QA, and Drug Safety Officers.
The large portfolio of services offered by PQE Group permits Veterinary companies to have a unique provider that can support, in addition to RA and PV services, all other GxP areas and computer software validation services.
4) Consulting is becoming a popular career path, particularly for scientists and medical professionals. What, in your opinion, are the top skills needed to be successful in a life science-focused consulting role?
My personal thought on being a life-science-focused consultant is that it is a job that requires you to always remain updated on current trends and opportunities to face new challenges and learn about different types of organizations. The consulting life allows you to be challenged every day on different topics and to continually expand your personal knowledge and qualifications. A new project with a new client always requires new solutions to different challenges; a life-science consultant must be flexible and open-minded to find the best solutions for the client to maintain compliance with all applicable regulations.
5) Now for the fun question – what is the best piece of advice that you’ve ever been given?
The best piece of advice that I have received is “Don’t think you’re always right, compare yourself with your colleagues and follow the path you think is best.” That means that all the problems and solutions that we are challenging should be shared with colleagues and clients in order to make the best possible decisions.
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