A Day in the Life:
Responsibilities may include the following and other duties may be assigned:
- Monitor the company’s drug or medical devices surveillance program, including intake, protocol development, evaluation, processing, and follow-up on adverse reports.
- Participate in the resolution of any legal liability and ensure 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 ADE data extraction and integrate the data to ensure the creation of a unified database consistent with ADE standardization and internalization.
- Ensure the 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:
- 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 direct the work of lower-level professionals.
- Majority of time spent delivering and overseeing projects from design to implementation while adhering to policies using specialized knowledge and skills typically acquired through advanced education.
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 a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) for degrees earned outside the United States).
- 0 years of experience required.
Physical Job Requirements:
The above statements describe the general nature and level of work being performed by employees assigned to this position but are not an exhaustive list of all required responsibilities and skills.
Benefits & Compensation:
Medtronic offers a competitive salary and flexible benefits package. A commitment to our employees lives at the core of our values. We recognize their contributions and share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
