Kelly Gidwani, DNP, MPH, RN

Drug Safety and Pharmacovigilance Leader
FDA
Waldorf, MD 20603

Kelly Gidwani, DNP, MPH, RN, is a Drug Safety and Pharmacovigilance leader with more than 20 years of experience spanning public health, clinical nursing, and federal healthcare oversight. She currently serves within the U.S. Food and Drug Administration, where she focuses on drug safety strategy, risk management, signal detection, and regulatory decision support across the product lifecycle. She holds a Doctor of Nursing Practice, a Master of Public Health, and a Master of Science in Nursing, with foundational academic training from Spelman College and the University of Toledo.

Her career began in public health, including work with the Centers for Disease Control and Prevention as a Prevention Specialist, where she supported HIV/AIDS education, reproductive health initiatives, and domestic violence prevention programs. She later transitioned into clinical leadership roles, including Clinical Director and Nursing Supervisor positions, where she provided direct oversight of patient care delivery and hospital operations. In 2021, she joined the FDA as a Health Scientist, expanding her impact to national and global drug safety efforts, including benefit-risk assessment, regulatory submissions, and cross-functional collaboration with scientific and clinical stakeholders.

Throughout her career, she has been recognized for integrating clinical insight with regulatory expertise to strengthen patient safety systems and improve healthcare outcomes. She serves as Vice President of the Nursing Foundation of Maryland and actively supports initiatives that advance nursing education and workforce development. Her professional philosophy centers on patient-centered care, health equity, and ensuring that safety decisions reflect both scientific rigor and human impact, informed by her dual perspective as a clinician and healthcare regulator.

• Medication Safety Certificate
• RN

• University of Massachusetts Amherst - DNP

• Full Scholarship - University of Toledo Master of Science in Nursing Program

• Sigma Theta Tau International Honor Society of Nursing
• The American Nurses Association
• The Nursing Foundation of Maryland
• Maryland Nurses Association

Q

What do you attribute your success to?

I attribute my success to a commitment to putting people first, the mentorship and training I have received from institutions and advisors, and an intentional focus on integrating research with clinical practice. I also rely on personal resilience to navigate challenges and continue growing in my work.

Q

What advice would you give to young women entering your industry?

I would advise young women entering my industry to center their work on the needs of people and their communities, while maintaining a strong commitment to self-care and self-awareness. I also encourage them to draw on both lived experience and rigorous training to advocate effectively for equitable access to care.

Q

What are the biggest challenges or opportunities in your field right now?

The biggest challenges and opportunities in my field include navigating complex healthcare systems across both clinical practice and federal regulatory environments, including the FDA landscape, while also addressing persistent gaps in access to care for underserved populations such as migrants, refugees, and marginalized communities. In addition, the work involves managing the emotional and clinical complexity of high-impact patient cases, including stillbirth and reproductive health trauma, as well as improving healthcare delivery amid cultural, language, and socioeconomic barriers that continue to influence patient outcomes.

Q

What values are most important to you in your work and personal life?

The values most important to me in my work and personal life are compassion, integrity, and a deep respect for human dignity in healthcare. I believe healthcare is fundamentally relational, requiring as much listening and understanding as clinical expertise, and I strive to see patients as whole individuals rather than diagnoses. Advocacy and health equity are also central to my work, particularly in supporting underserved and marginalized populations such as migrant workers, refugees, and women facing complex reproductive and medical challenges, with a focus on reducing barriers to care and ensuring they are seen and heard. I am also guided by integrity, accountability, and resilience, consistently striving to do what is right, remain transparent, and show up with strength and purpose even in challenging circumstances.

Locations

FDA

Waldorf, MD 20603