Global Case Management Associate

1 week ago


Ridgefield, Connecticut, United States McInnis Inc. Full time
Job Summary

We are seeking a highly skilled Global Case Management Associate to join our Patient Safety & Pharmacovigilance team at McInnis Inc. in Ridgefield, CT. The successful candidate will provide case processing and auditing support, ensuring the highest level of quality and accuracy in our safety database.

Key Responsibilities
  • Process and audit adverse event reports, ensuring compliance with regulatory requirements
  • Initiate follow-up query requests and monitor responses from adverse event reporters
  • Conduct reconciliation-related tasks, including Investigator Initiated Studies, License Partner's information, and Product Complaints
  • Support IND submission-related activities, ensuring timely and accurate submissions to the US FDA
  • Review Veeva reports for potential adverse events and act on them in a timely manner
Requirements
  • 4-year college degree
  • 2+ years of case report processing and auditing experience
  • Project management and administrative skills
  • Medical and clinical terminology
  • Strong communication skills
  • Proficiency in computer skills, with direct working experience in multiple electronic platforms


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