Behind the
Scenes
Patient safety is a responsibility shared by all Teva employees, but there’s one unit – Global Patient Safety & Pharmacovigilance (PV) – that monitors the safety of all Teva medicines worldwide, those that have received approval by healthcare regulatory authorities and Teva’s investigational drugs in clinical study. Any medicine, no matter how safe and effective, can sometimes cause side effects, also called adverse events (AEs). Adverse events can be relatively minor or life-threatening, but each one provides an opportunity for Teva to learn more about its patients and its medicines.
Monitoring the safety of medicines, or pharmacovigilance (PV), includes the detection, assessment, understanding and prevention of AEs and other possible drug-related problems. Pharmacovigilance activities include review and evaluation of suspected adverse reaction reports, published scientific literature and additional data produced from studies and programs. Teva PV continually assesses new and emerging safety data as it becomes available and takes quick and effective regulatory action as appropriate, in accordance with our governing PV laws and regulations. When there’s a connection between new adverse events and a medication, Teva PV works to identify ways to advance safer use of the medicine and communicates them to healthcare professionals and patients.
Meet two of Teva PV’s long-time employees. Órla Barron, a biochemist by background with a post-graduate master’s in pharmacovigilance & epidemiology, leads Teva’s Patient Safety Global Operations out of the company’s Ireland offices. Peter Gargya, a pharmacist with an MBA, is a deputy local safety officer for Teva in Debrecen, Hungary. Órla and Peter each have worked at Teva or its legacy companies for more than 25 years and share their thoughts on the winning formula for redesigning complex processes, the future of patient safety and how disconnecting from work re-energizes the mind.
Peter: My responsibilities include reporting adverse events involving Teva products marketed in Hungary by recording them in our global PV database. If I need more information about an adverse event, I contact the patient or healthcare professional who reported it.
Órla: I provide leadership and accountability for our global Patient Safety Operations (PSO) Teva network, a global team mainly in India, Israel and Romania. My team ensures that all of Teva PV’s patient safety data collection, analyses and supporting business processes, are designed and executed in an optimal, compliant and sustainable way.
Developing people and cultivating talent are important to me. I’m proud and privileged to lead my team, and I carefully match the capabilities and role profiles to ensure we can best serve Teva’s patient safety operational needs. I’m a strong advocate for in-house mentoring and talent development because I’ve been fortunate to have been surrounded by some strong business leaders and mentors at Teva. Most of all, I try to instill an ethos of enablement and empowerment so my team can bring their true value to Teva and the patients we serve.
Peter: I’ve had a front row seat as Teva developed into the global organization it is today. In the mid-1990s, the entire Teva Hungary marketing office was housed in an apartment. A colleague and I would try to predict the company’s future and imagine it becoming one of the largest generic drug companies in the world. Today, what seemed impossible at the time came true: Teva is one of the largest generics companies, but it’s never lost that family feel.
Órla: In 2012, when the Good Pharmacovigilance Practices (GVP) Modules were introduced in Europe, we’d print out literally hundreds of pages and highlight them with markers and post-it notes. Not very sustainable or what you’d find today! Pharmacovigilance has made numerous strides in digital innovation, and we continually explore ways to further enhance our PV systems landscape. What’s next? I can imagine greater use of artificial intelligence and the possibility of receiving the answer to a complex algorithm at the touch of a button, further leveraging of real-world AE data generation and, ultimately, touchless data which will take our patient safety data capabilities to an entirely new level.
Peter: PV has changed over the years, but the focus on patient safety remains constant. Advancements in technology and data will continue to influence how adverse events are analyzed and perceived. It’s important, of course, that we keep the patient at center and ensure we properly manage the quantity of data to avoid overcomplicating our PV work.
Peter: You could ask 10 PV colleagues and receive 10 different answers – and they’d all be correct! For me, empathy is the most important trait a PV employee can have. After all, we work for the well-being of patients. When there’s a heavy workload or the task at hand is challenging, I remember that everything we do in PV is for our patients. They’ve come to us with a question or observation about a Teva medicine, and it’s our responsibility and privilege to respond. The most important skills you need to succeed in PV? Precision, attention to details and commitment.
Órla: No two days are the same in PV, and it’s a really diverse and interesting sector so there’s never a dull moment! PV practitioners need to be very comfortable with the “grey” zones and making well- informed, balanced decisions. Solid, well-informed logic and out-of-the-box thinking are both critical skills to have when it comes to patient safety. There are also many opportunities in Teva PV – everybody’s voice is heard and everybody’s contributions are valued…
Órla: I firmly believe, for my team and for myself, that we need to be respectful of disconnection time, particularly during paid time off. It’s how we re-energize and come back stronger in mind, body and creative spirit. With three sons, a husband, a dog and two cats, home life is generally a flurry of activity, but on the weekends and vacation, we enjoy Formula 1, tennis, surfing and hiking. I’ve recently taken up zip-lining – it’s amazing what ideas come to mind when you’re several hundred feet off the ground!
Peter: Cycling has been my favorite sport since childhood – sometimes I bike to work, about three kilometers from home. I also enjoy badminton and gardening. Of course, the biggest joy is to be with family!