MDR Vigilance Specialist
Location:
Parkmore, Galway
Duration:
12 Months
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