Read Biography

Q&A

When did you realize you wanted to work in clinical safety and pharmacovigilance?

I realized early on in my educational pursuits that I had a passion for helping the public in the health sciences. I took my first Clinical Research Coordinator job in a small Psychiatric Practice while I prepared to pursue a graduate program in the field. It was then that I realized how much effort went into the research and safety of the patients, who sought new and novel therapies through clinical trials, that I shifted my focus to clinical research. My interest in working to improve how the safety data was collected, monitored, captured, and reported grew from there!

In your opinion, what is the greatest challenge in your field?

The greatest challenge in safety and pharmacovigilance is generating cross-functional engagement, understanding, and alignment with the long-term goals and requirements for ensuring a compliant and effective PV system that will allow potential and developed products to reach and remain safely on the market. Short answer: getting buy-in and funding to support long-term needs. In some cases, we (i.e., PV) are an afterthought!

What in your opinion is the biggest gap between research and practice in your field?

The patients and researchers involved throughout the development stage are trained to report safety information in a way the general public is not. When I train new teams or inquire with seasoned colleagues “how many times have you reported an adverse reaction,” I frequently find that people have experienced a product-related event but have not reported it. I believe we need to train our healthcare professionals and end-users (patients and their families) on their role in the continuous monitoring of the safety of each product.

What book are you currently reading and why?

I am currently reading Chicken Soup for the Soul. Being in a high pressure field with 24/7 demands and often high tension, it’s nice to read a good uplifting and heartfelt story to remind me that we are all human, all going through ‘something,’ and that how we treat others will be our ending legacy.

What advice would you give your younger self about to enter the “real world?”

Save your money! Just kidding (sort of!)… I would tell myself to slow down. I’m a very passionate person and have been in the work force since a very young age. This, coupled with my enthusiasm to learn, caused me to speed through career stages without taking a breath. I would tell myself that work will always be there, but family, friends, and personal health are the most precious!

What have you become better at saying “no” to? What approaches or realizations helped you?

I have become better at realizing my strengths and weaknesses and therefore am able to “say no” to projects in areas where I know there is a better suited individual to perform the activity than me.

Imagine a day without work, the internet, and any other obligations. What would you do?

Take my family camping, and I mean in a tent, not in a camper with a shower!

How has DIA helped you?

DIA was a resource for me when my access to global resources shrank due to a change in companies! I moved from a large global CRO to a small local organization and needed to have that global network of like-minded individuals for support and education in the safety and PV space. DIA reached out to me to help jump-start the CSP Community, and through that I’ve developed lasting friendships, expanded my professional network, and continue to improve on my education and understanding not only of the PV space, but of all of the other disciplines DIA supports. Being able to query someone in regulatory, quality, project management, or data management (any of them really), has been immensely helpful in my overall understanding of the complex network in drug/product development. DIA has helped me foster my passion for this industry, and I’m forever grateful for the friends and connections I’ve made through them. Thank you!

BIOGRAPHY

Catherine Baldridge is a Safety and Pharmacovigilance Consultant with more than 15 years in the industry. She is an active DIA member, former Chair of the DIA CSP Community, and currently serves as a member of the DIA Community Leadership Counsel. Catherine received her undergraduate degree in Psychology at Hollins University, and her Masters of Science degree in Clinical Research and Health Evaluation from the University of Virginia. Catherine resides just outside Richmond, Virginia, and when not focusing on GvP/GxP activities, she loves spending time with her friends and family at the beach.