Medical Specialists We All Need but Never See: Safety Physicians

While most people consult medical specialists at some point in their lifelong healthcare journey – cardiologists, dermatologists, gastroenterologists, for example – there is one medical specialist almost everyone relies on, but we never see in a doctor’s office: safety physicians.

Safety physicians specialize in evaluating the safety of investigational medicines in clinical studies and drugs that have received regulatory approval. It’s quiet, office-based work away from clinical exam rooms and operating suites, but the contributions safety physicians make to patients’ health often speak volumes. As part of a team of pharmacovigilance, or patient safety, experts, safety physicians empower healthcare providers and patients by equipping them with the ability to understand the benefits and risks of the medicines they take.

In recognition of annual World Patient Safety Day on September 17 and the important work safety physicians do, meet Bianca Neculai, M.D., and Antoanela Stanilescu, M.D. They are both associate directors in Teva’s Global Patient Safety and Pharmacovigilance unit and based in Bucharest, Romania. Bianca supports safety activities for generics and some mature branded products, and Antoanela assesses safety for primarily investigational medicines. Both have much to share about their important, but not widely known, medical specialty and how it supports patients.

Choosing Safety Medicine

Bianca: I went to medical school and enjoyed it, especially pharmacology, but I always knew I was better suited for medical research. After graduation, I went right into the pharmaceutical industry as a safety physician. It was the right role for me because it gave me an opportunity to use my love of research to better understand the risks and benefits of medicines and contribute to patients’ well-being. Today, I wouldn’t trade my career path for anything! My family sometimes asks if I’d be happier at a hospital or in a clinical practice, but I’m good where I am now. It’s what I am made for!

Antoanela: My journey was quite different than Bianca’s. I graduated from medical school, completed a dermatology residency and enjoyed working with patients at a hospital. Then, I met someone who worked in pharmacovigilance, and I was intrigued. I thought, “Wow, this field is really interesting.” I made the career change after realizing that as a safety physician, you are kind of a watchdog. You are there to protect patients, and not just one by one, but whole populations at a time. I really like having that kind of impact!

What It’s Like to be a Safety Physician at Teva

Bianca: Safety physicians are involved in all phases of a medicine’s development. For instance, in clinical development, we’re looking at such aspects as safe dosage amounts for humans and potential risks that may require monitoring. With an approved, marketed medicine, we aim to increase our understanding of its benefit-risk profile.

My job involves a lot of reading, analysis and recording. Every finding has to be documented! There are many times where I must complete tasks urgently to meet critical deadlines. It’s then when I most appreciate the Teva team around me as I always have their full support.

For me, acquiring knowledge is the most interesting and relaxing thing about my job. I read a lot of scientific literature, and we have access to clinical trial data databases and can learn about innovations in medicine worldwide.

Antoanela: The most appealing part of my job is the variety of work that I do. Every day brings something new, from novel safety topics to questions from regulatory authorities. In my role supporting clinical development, I could be analyzing adverse event reports, reviewing clinical trial protocol from a safety perspective, or participating in the design and conduct of clinical trials to ensure participants’ safety and data integrity.

In the morning, I do mostly individual work, where I analyze data or write documents. In the afternoon, I participate in cross-functional meetings with colleagues across the world where I might share a project update or provide my opinion as part of a team decision-making process.

Teva has a very good culture and people respect each other. Even with all those deadlines Bianca mentioned, I know I have the support of my manager and colleagues!

Keeping Patients Front and Center

Bianca: Safety physicians look out for patients’ best interests even though we are not in clinical practice. For example, because of a genotoxicity report I wrote regarding a certain medicine, recommendations for the use of contraception post-drug completion were extended from three to seven months for females and three to four months for males. That was a significant update and very important for couples who want to take all the measures possible to have a successful pregnancy and a healthy child.

Antoanela: I feel connected with patients, not only because of my history as a doctor, but because I’m a patient, my friends and family are patients – everyone is a patient. I still remember a time when I felt especially connected to patients; young teenagers taking an antibiotic were experiencing side effects, some of which were very serious. My job was to analyze the data, which led to an assessment and recommendations to minimize the risks. Now there is a labeling code that brings potential risks to physicians’ attention so they can make the best prescribing decisions for their patients.

The Future for Safety Physicians

Bianca: Unquestionably, we’re seeing the influence of artificial intelligence (AI) in our work, and it will only continue to grow. Artificial intelligence can be useful for automating routine tasks, but it cannot replace the human brain.

Antoanela: I agree technology is changing the landscape, and while there are challenges, I believe apps and online platforms can help us better communicate drug safety messages to patients. I don't think our roles as safety physicians will be threatened by technology very soon, and I’d actually like to see AI used even more for the routine tasks of our roles.

If You Remember One Thing About Safety Physicians…

Bianca: We are partners in patient health even though we don’t practice clinical medicine. Our goal is to empower patients to understand the benefits and risks of the medicines they take, resulting in better health outcomes for all.

Antoanela: Our work doesn’t stop after clinical trials or when a drug receives regulatory approval. We are committed to patient safety whether a medicine is investigational or has been marketed for two months or 20 years.

This content represents the opinions of the contributors and does not necessarily reflect those of Teva Pharmaceuticals. All content is aspirational in nature, is intended for informational and educational purposes, and should not be considered for any product recommendations. Consult a qualified medical professional for diagnosis and before beginning or changing any treatment regimen.

NPS-ALL-NP-01358 August 2024

Find out more:

• Klaudija Marijanovic Barac shares 3 trends she’s watching in patient safety.
• Discover our winning formula for patient safety at Teva.
• Meet Sebastian Horn, Teva’s Head of Global Patient Safety and Pharmacovigilance.
• Learn how pharmacovigilance keeps patients safe by reading “A Journey into Patient Safety.”
• Would you like to be a part of our team, helping to improve patients’ lives? Check out our Careers page!