Shraddha Borude

About Shraddha Borude

Detail-oriented Clinical Data and Safety Professional with strong expertise in SAS programming (Base, Advanced, Macros – SAS 9.4) and a solid understanding of CDISC standards, including SDTM and ADaM. Skilled in statistical analysis using PROC MEANS and PROC LOGISTIC, as well as SQL programming for data extraction, transformation, and validation. Experienced in handling and importing data from diverse sources such as Excel, CSV, MS Access, and SQL Server.Proficient in the end-to-end processing of safety cases, including case intake, triage, adverse event data entry, MedDRA coding, narrative writing, and listedness assessments. Demonstrated success in supporting the preparation and submission of expedited and periodic safety reports to global regulatory authorities, ethics committees, investigators, and internal stakeholders while meeting all regulatory and study-specific timelines.Adept at database reconciliation, documentation management, and working within Quality Management System (QMS) frameworks, including SOPs and Work Instructions. Known for strong cross-functional collaboration, attention to detail, and maintaining compliance with FDA, ICH-GCP, and global regulatory requirements.Committed to delivering high-quality safety and clinical data outputs while supporting efficient, compliant, and transparent clinical trial operations. Email: S••••••••@gmail.com

Experience

1. Safety Science Analyst

   Fortrea

   Jul 2025 — Present · Pune, IN

   Perform case intake and triage of the incoming safety information or reports from various sources either spontaneously or from a clinical trial• Assist with processing of the adverse events, including but not limited to: Data entry of safety data onto adverse event tracking systems. Write patient narratives & code adverse events accurately using MedDRA (for Marketed products, if applicable). Assist in the listedness assessment against appropriate label (for Marketed products, if applicable). Assist in generation of queries and collection of missing or discrepant information in consultation with medical staff, if needed. Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines.• Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel etc.), and prioritize the reports for processing and submission within the regulatory and/or study specific applicable timelines• Assist in the reconciliation of databases, as applicable. Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc. as appropriate• Assist in the maintenance of supporting files/ documentation regarding adverse event reporting requirements in all countries, if applicable• Support upload/archival of case/study/project documentation, as appropriate• Build and maintain good PSS relationships across functional units• Support compliance of operations with governing regulatory requirements• All other duties as needed or assigned

Education

• Jijamata Junior College Ahmednagar

  HSC, Science

• Shri. Vridheshwar High school Ahmednagar

  SSC, Semi English

• Savitribai Phule Pune University

  Bachelor of Pharmacy - BPharm, Pharmacy