MDR Vigilance Specialist
Location: Parkmore, Galway
Duration: 12Months
Job Type: Onsite

Position Overview

Responsible for monitoring and managing the company’s drug and medical device safety surveillance programs, ensuring accurate reporting and compliance with regulatory requirements. Reviews and analyzes adverse event data, integrates safety information into unified databases, and supports process improvements to enhance data quality. Serves as a liaison between internal teams and external partners to meet reporting standards. Operates as an independent specialist, managing moderately complex projects and contributing to cross-functional initiatives. Requires a university degree and at least 2 years of relevant experience.

Responsibilities

• Monitor the company’s drug or medical device surveillance program, including:

  • Intake, protocol development, evaluation, processing, and follow-up on adverse reports.

  • Participation in the resolution of any legal liability.

  • Compliance with government regulations.

• Ensure 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 analyze clinical databases for extraction of ADE data.

• Integrate ADE data to create a unified database aligned with standardization and internalization goals.

• 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.

Specialist Career Stream

• Individual contributor role with responsibility in a professional discipline or specialty.

• Delivers and/or manages assigned projects, collaborating with other stakeholders to achieve results.

• May mentor colleagues or guide lower-level professionals.

• Focuses on project delivery from design to implementation while adhering to company policies.

• Utilizes specialized knowledge and skills typically acquired through advanced (university-level) education.

Differentiating Factors

Autonomy:

• Works independently with general supervision on moderately complex projects or assignments.

• Established and productive individual contributor.

Organizational Impact:

• Sets objectives for own job area to align with project and assignment goals.

• Contributes to project milestones and may participate in cross-functional initiatives.

Innovation and Complexity:

• Handles general problems and issues, sometimes requiring understanding of broader job areas.

• Recommends system or process enhancements to improve effectiveness.

Communication and Influence:

• Communicates primarily with internal contacts; external interactions are limited or problem-solving in nature.

• Shares information, status updates, and needs to inform and support decision-making.

Required Knowledge and Experience

• Practical knowledge and demonstrated competence in the relevant job area.

• Typically obtained through advanced education combined with hands-on experience.

• Education: University degree required.

• Experience: Minimum of 2 years of relevant professional experience
  
  Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters 

   For further information on this role please contact Geraldine Gormally on 0861071395  / recruit@hero.ie 

  Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/   

  Please 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 your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.