Adverse Event Manager

hace 4 días


San José, San José, Costa Rica Genpact A tiempo completo
Job Summary

The Medical Device Reporting Analyst will be responsible for coordinating and executing medical device reporting activities within the organization. This includes managing the reporting process, conducting investigations, and providing support to cross-functional teams.

Duties and Responsibilities
  • Develop and maintain accurate and complete documentation related to adverse event reports.
  • Prepare and submit medical device reports to regulatory authorities within prescribed timelines.
  • Collaborate with quality assurance, regulatory affairs, and medical affairs teams to gather relevant information for reporting purposes.
Requirements
  • Experience working with complaint management systems.
  • Familiarity with adverse event reporting requirements and processes.
  • Strong communication and interpersonal skills.

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