Assoc MDR/Vigilance Specialist
Duration: 12 months
- 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
- Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
- May act as a mentor to colleagues or may direct the work of other lower-level professionals.
- The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
- Bachelor’s degree (Level8 NFQ) in Engineering/Science or related discipline and preferably with 1 -2 years relevant experience in a medical devices or related environment
- Candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered
- Dynamic team player who can work effectively and proactively on cross-functional teams
- Experience/understanding of complaint handling or CAPA processes are desirable. Candidates must be able to think critically and make sound decisions
- Candidates must be focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behaviour
- Candidates must be a good communicator and are fluent in English, both in writing and speaking.
To apply for this position please contact Keeva O’Shea at Sigmar Recruitment T: +353 91 749264 E: email@example.com
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