Our client a major multinational based here in Galway are looking to hire an Assoc MDR Vigilance Specialist on an initial 12 month contract.
This is a Hybrid role - 2 days in the office per week.
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 analyse 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 Requirements: Bachelor's degree (Level 8 NFQ) in Engineering/ Science/ Legal/ Clinical or related discipline.
1-2 years relevant experience in a medical devices or related environment preferred.
Dynamic team player who can work effectively and proactively on cross functional teams.
Ability to think critically and make sound decisions.
Strong attention to detail Knowledge of basic anatomy, physiology, and medical terminology Must be focused on patient safety and customer service, set high standards, instill operational excellence, drive accountability and model ethical behavior.
Good communicator and fluent in English, both in writing and speaking.
For more information and a confidential discussion on the role please contact Michelle Mc Inerney.
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Skills: Regulatory Affairs Specialist