Associate MDR/Vigilance Specialist Role
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The role involves monitoring 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 compliance with government regulations is also a key aspect of this position.
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Key Responsibilities:
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* Monitor the company's drug or medical devices surveillance program, ensuring complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required.
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* Participate in the resolution of any legal liability and comply with government regulations.
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* Review and analyse clinical databases for the extraction of ADE data and integrate 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.
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* Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
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* Deliver and/or manage projects assigned and work with other stakeholders to achieve desired results.
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Required Skills and Qualifications:
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Bachelor's degree (Level 8 NFQ) in Engineering/Science or related discipline or candidates with a legal or clinical qualification are preferred. An entry-level individual contributor on a project or work team, working with close supervision, is ideal. Good attention to detail, organisational and communication skills are essential.
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Benefits:
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This contract role offers hybrid working options and a 12-month tenure. It is an opportunity to gain experience in a dynamic environment and contribute to the success of the company.
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Please note:
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Candidates must have the correct visa to live and work in Ireland.