Gita brings more than 20 years of experience at the FDA, with deep expertise in pharmacovigilance, global risk management, and patient-centered benefit risk assessment across the product lifecycle. Her work has helped shape how Risk Evaluation and Mitigation Strategies are designed, evaluated, and implemented in practice, including leading the development of the FDA’s REMS Logic Model.

Throughout her career, Gita has partnered with global regulators, academic institutions, and cross-functional teams to advance regulatory science and improve real-world safety outcomes.

At PPV, Gita leads regulatory strategy for clients, bringing an ex-regulator perspective to complex safety, risk management, and benefit-risk challenges.