Senior Manager, Global Patient Safety

4 weeks ago


Uxbridge, United Kingdom Regeneron Full time
About the Role

We are seeking a highly skilled and experienced Senior Manager, Global Patient Safety to join our team at Regeneron. As a key member of our Global Patient Safety team, you will be responsible for leading the initial intake of adverse event data and subsequent reporting of Individual Case Safety Reports (ICSRs) to health authorities, collaborators, and internal destinations in compliance with global regulations and contractual obligations.

Key Responsibilities
  • Contribute to intake responsibilities for Argus events, including all aspects of ICSR submission start-up process
  • Track and monitor ICSR timelines to ensure submissions to regulatory agencies, collaborators, internal destinations, and contract research organizations (CROs) are aligned
  • Proactively investigate potential issues or noncompliance and raise trends and critical issues to management
  • Lead investigations of non-compliance issues and identify root cause for late ICSR submissions
  • Address and implement appropriate corrective actions related to ICSR submission activities
  • Assist in the management and oversight of ICSR transmissions between the PV Intake Tool and Argus database and from collaborators to Argus database
  • Proactively identify and lead continuous improvement/quality system initiatives through evaluation, development, and roll-out of process efficiencies applicable to all deliverables
  • Author new and update existing SOPs and working instructions, and conduct related training
Requirements
  • Minimum of Bachelor's Degree, Master's Degree preferred, in one of the life sciences or clinical research and/or licensed healthcare professional required
  • Previous experience in drug safety and safety reporting in pharmaceutical/biotech industry is required with minimum of 8 years
  • Able to independently and expertly identify, analyze, and problem-solve complex issues and trends
  • Strong knowledge and understanding of clinical research process and global pharmacovigilance regulations, systems, and processes


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