Regulatory Safety Reporting Process Enhancement

August 2022 – January 2023

At Premier Research, enhanced the regulatory safety reporting process for multiple therapeutic areas. Standardized documentation templates, introduced digital tracking tools, and streamlined communication with stakeholders, resulting in a 12% reduction in client complaints and 100% audit pass rate.

Skills Used

  • Safety Data Review

  • Regulatory Compliance (ICH E2E)

  • Document Standardization

  • Stakeholder Collaboration

  • Digital Workflow Optimization

  • MedDRA, Adverse Event Reporting