3 Days Left) Associate MDR/Vigilance Specialist

3 weeks ago

Galway, Galway, Ireland PE Global Full time

Associate MDR/Vigilance Specialist Role

We are recruiting for a highly skilled Associate MDR/Vigilance Specialist to join our team at PE Global. This is a 24-month contract role with hybrid working options.

Key Responsibilities:

  • Monitor the company's drug or medical devices surveillance program, including intake, protocol development, evaluation, processing, and follow-up on adverse reports.
  • Participate in the resolution of legal liability and compliance with government regulations.
  • Ensure accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data, or adverse reaction data as required.
  • Review and analyze clinical databases for the extraction of ADE data and integrate it into a unified database.
  • Act as a liaison internally and externally to develop programs and processes that meet regulatory reporting requirements.
  • Deliver and manage projects assigned, working with stakeholders to achieve desired results.
  • Ensure the highest quality of product event data entry for accuracy of reporting to regulatory agencies.
  • Identify and address problems, making minor changes in systems and processes to solve them.

Requirements:

  • Bachelor's degree in Engineering/Science or related discipline or candidates with a legal or clinical qualification.
  • Entry-level individual contributor on a project or work team, working with close supervision.
  • Good attention to detail, organizational, and communication skills.

Working Environment:

  • Hybrid working options available.

Additional Information:

  • Candidates must have the correct visa to live and work in Ireland.

Skills:

  • MS Office Suite
  • MDR Reg Affairs
  • Science
  • Med Device control systems

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