Job Description
Top 3 things the manager is looking for:
1. Previous MDR experience.
2. Nursing or other health care professional experience.
3. Prior work with a medical device company
Top 3 Tasks or Responsibilities in scope for this role: 1. Reviewing and documenting incoming medical device complaint info.
2. Making decisions on whether or not a report to the FDA is needed.
3. Reaching out to the field for further info on complaints
Education Required: Completed Bachelors Degree
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 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 : Entry-level individual contributor on a project or work team. Works with close supervision.
Organizational Impact : Delivers work of limited scope, typically smaller, less complex projects or related activities.
Innovation and Complexity : 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.
Communication and Influence : 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.
Required Knowledge and Experience :
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), 0 years of experience required.
PHYSICAL JOB REQUIREMENTS - The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
Nice to Have Good knowledge of complaint coding, the basics for complaint handing process, making correct Reg Rep reportability decisions,
Learning Minset (Quick Learning)
Time Management skills, Accountability, WIP Mgmt, Good Communications, Asking questions, Basic understanding of your contacts, Willing to work hybrid, Interpersonal skills= Team player (works well within the team) Collaboration
Basic problem solving: Being able to ID an issue and propose a possible solution or escalate appropriatly
Working in an office transactional desk based work.
Science based degrees helpful
Develop basic knowledge of Microsoft programs, outlook, teams,
Manage Deadlines, basic organizational skills, ability to participate in projects, basic project process understanding / skills.
Job Tags
Contract work, Work at office, Local area, Immediate start,