Clinical Safety Reporting Specialist

$80,000 - $120,000/Yr

Medtronic - Minneapolis, MN

Full-time - Mid Level

Minneapolis, MN

10,001+ employees

Miscellaneous Manufacturing

About the position

The Clinical Safety Reporting Specialist at Medtronic is responsible for managing safety and potential complaint data throughout clinical studies to ensure compliance with regulatory requirements. This role involves collaboration with various teams within Medtronic to ensure timely and accurate reporting of clinical safety data, acting as a liaison for safety-related inquiries, and supporting the preparation of clinical safety documentation.

Responsibilities

• Ensure that all Clinical Safety data is assessed consistently against reporting requirements (e.g., PMDA).
• Interact with investigational sites and clinical 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).
• 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, 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.

Requirements

• Bachelor's degree with 2+ years of clinical research experience or an advanced degree with no experience.
• Basic knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.

Nice-to-haves

• Prior Medtronic experience.
• Safety experience.
• Fluent with medical terminology.

Benefits

• Competitive Salary
• Flexible Benefits Package
• Short-term incentive called the Medtronic Incentive Plan (MIP)