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Assoc MDR/Vigilance Specialist | Hybrid

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 20097

Our client a major multinational here in Galway are looking for an Assoc MDR/Vigilance Specialist on an initial 12 Month contract.


This is a Hybrid role.


Responsibilities:

  • Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
  • Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
  • Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.
  • Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
  • Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.

  • Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.
  • Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision.
  • Innovation and Complexity: Identifies, defines, and addresses problems that are not immediately evident but are typically not difficult or complex. Makes minor changes in systems and processes to solve problems.
  • Communication and Influence: Communicates primarily with internal contacts within the immediate group. Contacts others to gather, confirm and convey information. Leadership and Talent Management: N / A – a job at this level is focused on self-development

Requirements:

  • Requires broad theoretical job knowledge typically obtained through advanced education.
  • Requires a level 8 in a relevant area of study.

For more information on this role and a confidential discussion please contact Michelle Mc Inerney on

091 706 717 or email michelle.mcinerney@collinsmcnicholas.ie.