Associate MDR Vigilance Specialist

Summary:

Responsibilities for this role include reviewing product events from a variety of sources to determine the complaint status and create the complaint record in the complaint handling system. This role is also responsible for determining the regulatory reporting status, completing the regulatory report, and ensuring timely submission. Responsibilities of this role also include conducting follow-up with internal and external contacts to ensure complete complaint information is obtained as well as evaluating incoming information for Medical Device Reporting and Vigilance Reporting eligibility.   

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.
• 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.
• Delivers work of limited scope, typically smaller, less complex projects or related activities.
• Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems.
• Communicates primarily with internal contacts within immediate group.
• Contacts others to gather, confirm and convey information. Leadership and Talent Management: N / A – job at this level is focused on self-development.

Requirements:

• Requires broad theoretical job knowledge typically obtained through advanced education.
• Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A).