MDR – MDR​/Vigilance Specialist

Top 3 skill sets required:

• Complaint handling experience
• Knowledge of IMDRF or complaint coding is a plus
• Project management

Three main responsibilities/day to day activities required for this role:

• Map complaint code to categories
• Update Work Instructions accordingly
• Work with a cross-functional team

Product(s) supported: Cardiovascular Surgery products

Target years of experience: 3-5 years

Responsibilities may include the following and other duties may be assigned. Monitors the company’s drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and followup 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.

SPECIALIST CAREER STREAM:
Typically an individual contributor with responsibility in a professional discipline or specialty. 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 (typically University).

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, gain 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.

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