Medical Device Surveillance Specialist

3 days ago

Galway, Galway, Ireland beBeeVigilance Full time €41,000 - €54,100

Associate MDR/Vigilance Specialist

About the Role

This entry-level position involves monitoring our drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports.The successful candidate will participate in the resolution of any legal liability and ensure compliance with government regulations.Maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data, or adverse reaction data as required by regulatory agencies is a key responsibility.The role also involves reviewing and analyzing clinical databases for the extraction of ADE data and integrating the data to ensure the creation of a unified database.Supporting ADE standardization and internalization to ensure accuracy and quality of safety summaries is another critical task.The Associate MDR/Vigilance Specialist will act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.Delivering and/or managing assigned projects and working with stakeholders to achieve desired results is an essential part of this role.The successful candidate may mentor colleagues or direct the work of lower-level professionals.

Requirements

Entry-level individual contributor with responsibility in a professional discipline or specialty.Works with close supervision.Delivers work of limited scope, typically on smaller and less complex projects.Identifies and addresses problems that are typically not difficult or complex; makes minor changes to systems and processes.Communicates primarily with internal contacts within the immediate group to gather, confirm, and convey information.Focuses on self-development; no leadership or talent management responsibilities at this level.Requires broad theoretical job knowledge, typically obtained through advanced education.

Why You'll Love This Role

  • This role offers an exciting opportunity to contribute to the success of our organization.
  • You will have the chance to work on challenging projects and develop your skills and expertise.
  • A collaborative and dynamic work environment makes this role ideal for someone looking to grow and learn.

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