Sneha Joshi

Experience

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  Watson Pharmaceuticals

  May 2018 - Jun 2018

  Formulation and Analytical R & D Intern

  • Executed in-depth analysis of manufactured oral tablets utilizing dissolution processes and HPLC chromatography technique, following Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) guidelines• Examined 15+ SOPs to gain an in-depth comprehension of industry standards and Good Documentation Practices (GDP) principles

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  Tata Consultancy Services

  Jun 2019 - May 2022

  Drug Safety Associate

  • Managed the reporting of over 9000 adverse event complaints for drug and drug-device products globally, translating data into Individual Case Safety Reports (ICSRs) in compliance with ICH E2B and Good Clinical Practices (GCP) standards• Evaluated seriousness, causality, and labeling of spontaneous post market surveillance reports, clinical trials including SUSAR, product complaints, malfunction, and follow-up reports• Engaged with global regulatory bodies FDA, EMA, and MHRA to address queries on MedWatch, CIOMS, and Rave forms, resulting in improved regulatory compliance and streamlined customer complaint handling processes• Implemented data correction strategy for 4000+ ICSRs, analyzing error trends by applying KPI metrics to foster clinical data management, and enhance regulatory submission accuracy, resulting in improved product life cycle efficiency• Directed and mentored over 40 junior associates, implementing daily check-ins and client feedback loops; reduced overall error rate by 35% within the first quarter, enhancing team efficiency and client satisfaction• Coordinated during audits and regulatory inspections, ensuring zero critical issues• Conducted detailed root cause analysis and filed CAPA for late and incorrect ICSR submissions• Achieved dual recognition as ‘Employee of the Month’ twice for ensuring 100% quality and devising strategic plan to decrease error score Show less

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  Purcell

  Apr 2024 - now

  Regulatory Affairs Intern - XN Project