Abhishek Shukla
Business Process Lead @Tata Consultancy Services
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WORK HISTORY
Business Process Lead @Tata Consultancy Services
Mumbai, IN
Managed regulatory submissions and product/organization data updates via EMA portal and SPORIFY.• Aligned Veeva RIMS data with ISO IDMP standards, ensuring submission readiness.• Configured and maintained SPOR domains (Substance, Product, Organization, Referential) for data consistency.• Coordinated SPOR ID procurement & validation for accurate EMA records.• Integrated vendor data into RIMS, enhancing data quality and compliance.• Performed PMS & OMS data validation to ensure correct master data mapping.• Streamlined IDMP workflows with Veeva automation tools, improving EMA compliance timelines.• Executed monthly SPORIFY updates for system alignment.• Managed xEVMPD submissions via XML and integrated submission tools, tracking Health Authority interactions.• Conducted gap analysis in Veeva RIMS to resolve discrepancies and maintain regulatory accuracy.
EDUCATION
Sainath Jr. College of Science and Commerce
HSC
VES college of Arts, Science and Commerce.
Bachelor's degree
Shri R.J Makecha high school
Schooling
VES college of Arts, Science and Commerce
Master's degree
ABOUT ABHISHEK SHUKLA
Regulatory Operations Specialist with 5+ years of diverse experience in Regulatory…
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