Clinical Safety Specialist at Medtronic

Rome, Latium, Italy

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s degree and a minimum of 2 years of relevant work experience
Practical knowledge and demonstrated competence within job area
Fluency in English
Prior work experience with Medtronic products and/or therapies (preferred)

Responsibilities

Review and assess clinical study safety data, including Adverse Events (AEs), Serious Adverse Events (SAEs), and device deficiencies
Identify potential unreported AEs or complaints through Case Report Form reviews and communication with study sites and monitors
Ensure consistency and regulatory compliance in the evaluation and reporting of safety events and device issues
Collaborate with Regulatory Affairs, Product Complaint, and Data Management teams to support accurate and timely reporting and documentation
Act as a key contact for safety-related questions and contribute to the development of safety management and reporting plans
Support audits, database reviews, and Clinical Event Committee (CEC) activities to ensure study quality and data integrity
Prepare safety-related sections of reports, participate in safety trend reviews, and contribute to continuous improvement of safety processes

Skills

Adverse Events

Serious Adverse Events

Regulatory Compliance

Safety Data Review

Case Report Forms

Clinical Study Safety

Device Deficiencies

Regulatory Reporting

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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