Associate MDR & Vigilance Specialist
Location: Parkmore, Galway
Duration: 24 Month Contract
Job Type: Onsite
Position Overview
The Associate MDR & Vigilance Specialist monitors and manages adverse event reporting for medical devices and/or drugs, ensuring compliance with regulatory requirements. The role involves analyzing clinical data, maintaining safety reports, and collaborating internally and externally to support vigilance programs.
Key Responsibilities
* Monitor the company’s drug or medical device surveillance program, including:
* Intake, protocol development, evaluation, and follow-up on adverse reports
* Participation in resolving any legal liability issues
* Compliance with government regulations
* Ensure complete and accurate maintenance and reporting of:
* Medical Device Reports (MDRs)
* Adverse Drug Experiences (ADEs)
* Adverse reaction data as required by regulatory agencies
* Review and analyze clinical databases to extract ADE data, integrating it to create a unified database consistent with ADE standardization and internalization
* Ensure accuracy and quality of safety summaries
* Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
* Individual contributor with responsibility in a professional discipline or specialty
* Delivers and/or manages assigned projects, working with stakeholders to achieve results
* May mentor colleagues or direct work of lower-level professionals
* Majority of time spent delivering and overseeing projects from design to implementation, adhering to policies and applying specialized knowledge
Differentiating Factors
* Autonomy: Entry-level individual contributor on a project or work team; works with close supervision
* Organizational Impact: Work of limited scope; typically smaller, less complex projects or related activities
* Innovation & Complexity: Identifies minor problems and makes small process or system changes
* Communication & Influence: Primarily communicates with internal contacts within immediate group; contacts others to gather, confirm, and convey information
Required Knowledge & Experience
* Broad theoretical job knowledge, typically obtained through advanced education
* 1–2 years of experience in a similar field
Seniority Level
Not Applicable
Employment Type
Full-time
Industries
Medical Equipment Manufacturing
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