Neha Sheth, Vice President, Pharmacovigilance Risk Management and Epidemiology, Medical & Development, was recently named a 2020 Luminary by the Healthcare Businesswomen’s Association (HBA). The HBA Luminary award recognizes women dedicated to the industry and who help advance other women’s careers. As Neha celebrates this prestigious award and 25 years of bringing innovative medicines to patients, she reflects on the importance of learning and leadership.

What is pharmacovigilance?

Pharmacovigilance is the science related to the collection, detection, assessment, monitoring, communication and prevention of adverse reactions throughout the life of healthcare products. Information received from patients and healthcare providers via clinical trials, as well as other sources such as medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place. All of this works to ensure the protection of our patients and the benefit of the general public health worldwide.

How did you land in pharmacovigilance?

It was a pure accident! While I felt that the University of Michigan School of Pharmacy trained us to stay on the clinical side, I was one of the few who decided to take a different path. During the last year of the PharmD program, I did a rotation at Pfizer. I was offered a job in the World Wide Drug Safety division and I haven’t looked back since. This is where I learned the fundamentals and worked my way into more complex activities like periodic reporting, signal and risk management, and epidemiology, which served as the foundation to build upon for  my position today.

What is one of the biggest changes you have seen during your 25 years working in pharmacovigilance?

Although the concept of monitoring the safety of medicines has been around for many years, the formality of being proactive and systematic that accompanies the field today was not there when I began my career in the mid 90’s. For example, formal job descriptions and training in risk management were not standard at that time.

What do you enjoy most about working in pharmacovigilance?

Every day is different. No two risk evaluations are the same. The constant variety and the complexity of what we do translates into continuous learning and never an opportunity for boredom.  The role requires interaction and collaboration with many different colleagues across the world which also really enhances the experience of working in pharmacovigilance.

Who has played an instrumental role in influencing you throughout your successful career?

I have been fortunate to work with many amazingly smart, successful and yet humble leaders in the healthcare industry. Working for Songlin Xue, Executive Vice President, Pharmacovigilance, Medical & Development at Astellas, I’m reminded of the importance of being considerate to the needs of our colleagues, as  human beings. I have learned the science of pharmacovigilance from Songlin, and his kindness and approachability are leadership qualities I aim to emulate. At Pfizer, the head of R&D taught me the importance of being able to relate to all functions including development, statistics and medical affairs -- tailoring your communications and being accessible to all.

What is most rewarding about your leadership role at Astellas?

While I sometimes miss the direct work with product teams from my earlier career days, there is nothing more rewarding than the pleasure of teaching, mentoring and watching others develop in their careers. I have so many talented individuals on my team and I always strive to be the strategic leader that remembers the importance of approachability, accessibility and teaching.

How do you support other women in healthcare?

As I welcome new challenges and successfully lead projects, I hope other women realize the opportunities they have to reach their full potential. I actively coach and support other women to create an environment of empowerment and advocacy that helps advance and inspire women at Astellas. I will also continue to build my mentorship activities through Astellas’ Stellar Women Employee Impact Group.