Asmita Gharde

Managed the ICSR Management Unit to ensure timely regulatory submissions and improved team efficiency through workload analysis and resource reallocation, driving on-time delivery and quality compliance. Led mentoring, productivity target setting, and CAPA oversight to improve operational performance across pharmacovigilance workflows.

Implemented data governance policies and data quality standards for critical safety datasets, improving integrity of regulatory reporting SLAs and enabling trusted executive analytics. Led cross-functional mapping of source systems and deployed anomaly-detection workflows to maintain daily data sanity.

Led a team of 25 in pharmacovigilance activities for clinical studies, conducting quality reviews, signal detection, and contributing to risk management strategies to ensure regulatory compliance. Trained new staff and resolved project-level issues to maintain consistent safety data quality.

Performed initial evaluation and processing of ICSRs from clinical trials and post-marketing sources, ensuring accurate data entry, literature screening, and compliance with local and global regulations. Improved completeness and timeliness of case reporting activities.

Managed clinical operations and provided treatment to a high-volume patient base (~800+ patients/month), focusing on treatment efficacy, patient retention, and practice profitability. Oversaw day-to-day clinic administration and patient care.

Provided treatment and managed clinical operations for a large patient volume (~1,300+ patients/month), demonstrating measurable treatment outcomes and driving references to support clinic growth.

Obtained Six Sigma Green Belt certification demonstrating knowledge of process improvement and quality methodologies.

Completed a Data Science Pro Degree program focused on data analysis, programming, and applied machine learning techniques.

Completed a Post Graduate Diploma in Clinical Research covering clinical trial processes and safety reporting.

Completed a Bachelor of Homeopathic Medicine & Surgery focusing on clinical training and patient management.