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Assoc. MDR/Vigilance Specialist

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Title: Assoc. MDR/Vigilance Specialist
Contract: 12 month Location: Parkmore, Galway. 

Main responsibilities:
  • Monitor company's drug and medical device surveillance program, including intake, evaluation, processing, and follow-up on adverse reports.
  • Ensure compliance with regulations and assist in legal resolution.
  • Maintain and report Medical Device Reports (MDRs) and Adverse Drug Experience (ADE) data accurately for regulatory agencies.
  • Analyse clinical databases to extract ADE data, create a unified database, and ensure accurate safety summaries
  • .Liaise internally and externally to develop programs meeting regulatory reporting requirements.
  • Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.
  • Makes minor changes in systems and processes to solve problems.

Main Requirements:
  • Bachelor’s degree (Level 8 NFQ) in Engineering/Science or related discipline.
  • Up to 2 years relevant experience
  • Dynamic team player, attention to detail, goal-orientated, good communicator and problem solving skill-sets.
  • Medical device experience desirable100% desk based

For further information on this role please contact Maraleeze Keane on 0864410614 /

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Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.
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