I am an experienced pharmacovigilance and clinical safety leader with over 17 years of expertise in managing global drug safety strategies across various therapeutics and biologics for multiple products including Oncology, Immuno-oncology, and Infectious diseases such as COVID-19, RSV, Flu. My career has been dedicated to ensuring the safety and efficacy of pharmaceutical products through strategic leadership, regulatory compliance, and cross-functional collaboration.
In my current role as Director, Clinical Safety Scientist at Moderna-Cambridge, USA, I have played a critical role in the establishing safety related procedures and management of the COVID-19 vaccine program, overseeing signal detection, safety assessments, and regulatory reporting. I have successfully led the development of key safety documents, including PBRERs and DSURs, while optimizing literature surveillance processes to enhance safety evaluations. My previous experiences at Millennium Pharmaceuticals (Takeda) and Alkermes have further solidified my expertise in pharmacovigilance planning, aggregate safety reporting, and regulatory submissions, including INDs, NDAs, BLAs and MAAs.
Beyond my leadership in pharmacovigilance, I am an active contributor to the scientific community. I have contributed to several high-impact research publications, focusing on drug safety, pharmacovigilance, and the long-term effects of pharmaceutical interventions. My work has been published in renowned journals such as Biological Psychiatry, CNS Spectrums, and Pharmacoepidemiology and Drug Safety, with leading academic publishers including Elsevier, Wiley, and Cambridge University Press.
Key Themes in My Research:
- Safety and Efficacy of Antipsychotics – A significant portion of my research explores the long-term safety and efficacy of antipsychotic medications, particularly olanzapine and samidorphan. My work has contributed to understanding their metabolic effects, weight management implications, and overall tolerability in patients.
- Pharmacovigilance and Benefit-Risk Assessments – I have been actively involved in structured benefit-risk assessments, utilizing real-world evidence to enhance drug safety evaluations and inform regulatory decision-making.
- Clinical Trials and Drug Development – My contributions span various phases of clinical trials, particularly Phase 3 studies, where I have played a key role in assessing drug safety and efficacy in large patient populations.
- Neuropsychiatric Disorders – Much of my research has focused on the treatment of psychiatric conditions such as schizophrenia, evaluating long-term patient outcomes and the impact of pharmacological interventions.
- Artificial Intelligence in Pharmacovigilance – My recent work explores the integration of AI into pharmacovigilance to enhance drug safety monitoring. AI-driven approaches, including predictive analytics, machine learning, and real-time data processing, are transforming adverse drug reaction (ADR) detection, risk assessment, and regulatory decision-making.
Through these publications, I have contributed to advancing the field of pharmacovigilance, clinical pharmacology, and real-world evidence analysis, reinforcing my expertise in drug safety and risk assessment methodologies. My work continues to support the development of safer and more effective treatment options for patients worldwide.
With a strong background in pharmacy, business management, and information systems assurance, I bring a strategic and analytical approach to safety and risk management compliance. I thrive in cross-functional environments, fostering collaboration among internal teams, regulatory agencies, and external stakeholders to drive efficient and effective safety oversight. My ability to lead, mentor and guide safety professionals further contributes to the development of strong pharmacovigilance teams. As I continue to advance in my career, I remain dedicated to enhancing drug safety, optimizing risk-benefit assessments, and shaping the future of pharmacovigilance practices in the pharmaceutical and biotech industries.