MDR | Vigilance Specialist

Job Description

Duties and Responsibilities:

• 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 analyze 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.

Differentiating Factors

Autonomy:

• Established and productive individual contributor.
• Works independently with general supervision on larger, moderately complex projects / assignments.

Organizational Impact: 

• Sets objectives for own job area to meet the objectives of projects and assignments.
• Contributes to the completion of project milestones.
• May have some involvement in cross functional assignments.

Innovation and Complexity: 

• Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .
• Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence:

• Communicates primarily and frequently with internal contacts.
• External interactions are less complex or problem solving in nature.
• Contacts others to share information, status, needs and issues in order to inform, Product input, and support decision making.

Leadership and Talent Management: 

• May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Qualifications:

• Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
• Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
• 3-5 yrs experience.
• Complaint handling experience.
• Handle complaint code and map it to new code.
• IMDRF code knowledge.
• Data mapping via Excel.