Clinical Safety Reporting Specialist at Medtronic in Minneapolis, Minnesota

Job Description:

We anticipate the application window for this opening will close on - 15 Nov 2024

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life
The Clinical Safety Reporting Specialist (business title) is responsible for safety and potential complaint data throughout the clinical study to ensure compliance with respect to the reporting of clinical study safety and potential complaint data to meet regulatory requirements. The MCRS Clinical Safety Reporting Specialist will partner with various colleagues across Medtronic (e.g., other members of the MCRS Clinical Safety team, other MCRS functions, Regulatory Affairs, Clinical teams in the Operating Units) to manage safety data reporting in compliance with applicable regulatory standards and Medtronic internal requirements.

Responsibilities may include the following and other duties may be assigned.

• Ensure that all Clinical Safety data is assessed consistently against reporting requirements (e.g., PMDA)


• Interact with investigational sites and clinical (field) monitors to obtain additional pertinent Clinical Safety information as indicated in the Clinical Investigation Plan (CIP)


• Work with Regulatory Affairs, Clinical Operations and Field Assurance to ensure timely reporting of all applicable Clinical Safety data to the Competent Authority (e.g., PMDA) including expedited reporting, annual reporting and other documents as needed


• Reply to inquiries from Competent Authority (e.g., PMDA) regarding submitted reports


• Act as liaison for all Clinical Safety-related questions (e.g., to study team, field support, monitors, and study sites)


• Provide input to or assist with preparation of assigned section of the Clinical Safety Management and Potential Complaint Plan (CSMPCP), CIP, Clinical Safety reports (e.g., annual reports), Clinical Study Reports, Investigator Brochure (IB), Case Report forms (CRF) and other documents/tools as required


• Support study audit for Clinical Safety-specific topics


• Perform other Clinical Safety tasks as assigned

Must Have: Minimum Requirements:

• Bachelor's degree with 2+ years of clinical research experience or an advanced degree with no experience

Nice to Have:

• Prior Medtronic experience


• Safety experience


• basic knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials


• Fluent with medical terminology

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

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. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$80,000.00 - $120,000.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 90,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here .

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.