A Qualified Person for Pharmacovigilance (QPPV) is personally responsible, by law, for the safety of the human pharmaceutical products marketed by that company in the EU. The QPPV must reside in the EU and should provide support across the globe through in-house QPPVs and a network of Local QPPVs.
Major Contender in Everest Group’s Pharmacovigilance and Complaint Management Operations – Services PEAK Matrix® Assessment 2021
When choosing a QPPV partner, it is important to select a partner with access to the best local experts, and who can provide scalable and customized solutions based on specific needs. At Navitas Life Sciences we provide integrated end-to-end solutions that extend beyond the role of the QPPV to include comprehensive management of safety reporting, lucid communications, and effective support to all stakeholders.
As this blog examines just what makes our QPPV services unique, we also explore the journey of our Head of Pharmacovigilance, QPPV, Dr. Philipp Hofmann, MD following his decision to move away from medical practice to the pharmaceutical world. Learn how he has applied his experience to evolve strategies that ensure the delivery of a world class PV system.
How do you become a QPPV?
If you study medicine, you will work as doctor. Engineering students will work on new technology, and, as a historian, you brood over the events of history. However, this does not apply to service providers and medical consulting. In no other industry, is there such diversity of people with the most varied academic careers.
We have our very own in-house example of such change and diversity in Dr Philipp Hofmann, MD, Head of Pharmacovigilance, QPPV at Navitas Life Sciences. Philipp first encountered the pharmaceutical industry back in 2006. At that time, he had just finished his study of human medicine in Marburg, Germany, and was preparing for his doctorial theses in nuclear medicine.
“I realized for the first time how much a medical professional is needed in the pharmaceutical world and what important contribution you can make to the success of products and projects based on your special medical expertise,” says the 42-year-old.
Dr Philipp Hofmann, MD
Head Pharmacovigilance, QPPV,
Navitas Life Sciences
Philipp initially devoted himself entirely to his career aspiration: to become a doctor in a hospital, preferably in patient care, but maybe also in research. Once, however, Philipp abandoned his purely medical career path: In the middle of his studies, he realized that in the pharmaceutical industry, pharmacists and medical doctors are mandatory. “I just wanted to explore how a physician can contribute to pharmacovigilance in the pharmaceutical world.” His father used to work in quality management in pharmaceutical production, and his sister stills work in medical marketing.
He liked the role from the time he was preparing for the application process. “Working on, structuring and solving medical questions - that is a lot of fun and I really like it.”
In the following years, Philipp supported several products and projects in the pharmaceutical industry and worked on it, in line with colleagues from a wide variety of academic backgrounds. “It was clear to me that I made the right decision in moving away from the medical practice to the pharmaceutical world.”
After joining Navitas Life Sciences, he is now responsible for several projects in the life science field as a QPPV together with an international team of doctors and natural scientists.
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Knowledge gaps are closed “on the job”
“As a doctor, I understand diseases, medical practice and health systems. That helps a lot to get used to related topics with medical relevance,” Philipp confirms.
There is an opportunity to familiarize oneself with complex, unknown issues in a short time, keep calm under pressure, find the right solutions in difficult conversations - immensely important asks for an employee in the service provider and the pharmaceutical industry.
There will always be questions that remain unanswered, however, there is the possibility to align with leading experts in life science, pharmaceutical or medical colleagues to include their point of view on the solutions developed in the team. “The mixture of business development, medical topics, pharmaceutical details, regulatory affairs, and last but not least, the open atmosphere at Navitas Life Sciences has enrichened my work.”
Leveraging some 30+ years of PV experience, we pride ourselves on our ability to support clients as they look to outsource the role of the QPPV. We offer tailormade solutions to cater to your unique needs, supported by a well-established network of local QPPVs who are helping our clients to meet specific local PV requirements in 20 countries.
Interesting CVs in Demand
A rewarding career at Navitas Life Sciences is certainly possible with any life-science background, says Philipp. Much more important than the course are creativity, perseverance, and ambition. Many of the Navitas Life Sciences’ team have exciting positions on their CVs that, at first glance, have nothing to do with the industry. Philipp himself used to live in Paris, France, for 4 years – a location which underlines the international aspects of his life.
Philipp cannot imagine going back to the laboratory or a clinic in the foreseeable future. The prospect of further exciting projects and the growing pharmaceutical market is too tempting. “I love my work at Navitas Life Sciences with my international colleagues.” In consequence, you don’t necessarily have to work as a traditional doctor to make a difference for patients.
“I love my work at Navitas Life Sciences with my international colleagues.”
- Dr. Philipp Hofmann, QPPV, Navitas Life Sciences
We are always looking for like-minded individuals with a passion to drive better outcomes through drug development and beyond. If you are a self-motivated individual looking to thrive in an environment filled with opportunities and innovation and are willing to support in taking life-saving drugs to market sooner, then click here to find out more.