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Experienced medical professional with over a decade of expertise managing the end-to-end pharmacovigilance lifecycle and benefit-risk profile for both development molecules and post-marketed products across global regulatory environments. Proficient in drafting and managing Aggregate Safety Reports (ASRs), including PBRERs, PADERs, DSURs, INDs, NDAs, and localized Risk Management Plans (RMPs). Skilled in leveraging signal detection tools like Empirica and Rxlogic, with strong capabilities in end-to-end signal management processes encompassing detection, prioritization, validation, in-depth analysis, and communication of safety signals with actionable recommendations. Extensive hands-on experience in supporting clinical trial development molecules, including signal detection and ongoing safety monitoring for early- to late-phase clinical trials. Experienced in collaborating with cross-functional clinical development teams to provide safety input on study protocols, investigator brochures (IBs), and informed consent forms (ICFs). Collaborates effectively with cross-functional teams, including clinical development, regulatory affairs, medical writing, and global safety groups, to ensure comprehensive safety oversight throughout clinical development and post-marketing phases. Skilled in conducting in-depth safety data review using line listings, clinical databases, and ARGUS, supporting periodic safety evaluations, labeling updates, and safety responses to regulatory queries. Proficient in case processing, training teams on case handling protocols, performing medical coding reviews, and conducting medical evaluations. Focused expertise in therapeutic areas such as Oncology, Central Nervous System, and Cardiovascular System. In-depth knowledge of Good Pharmacovigilance Practices (GPV), ICH guidelines, and FDA/EMA regulatory requirements.

• June 2015 – BLS Certification
• July 2015 – ACLS Certification
• September 2013 – ECFMG Certification
• June 2011 – Indian Medical Council