Clinical Safety Specialist

1 settimana fa

Roma, Lazio, Italia Medtronic A tempo pieno 60.000 € - 120.000 € all'ano

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 LifeAs a Clinical Safety Specialist, you will play a key role in ensuring the highest standards of safety and compliance throughout the clinical study process. You will be responsible for monitoring safety data and potential complaints, making sure all reporting meets regulatory and internal requirements. Your work will help ensure that clinical study data are handled with accuracy, transparency, and care, contributing directly to patient safety and study integrity.

In this role, you will collaborate closely with colleagues across Medtronic — including members of the MCRS Clinical Safety team, other MCRS functions, Regulatory Affairs, and Clinical teams within the Operating Units. Together, you will manage the reporting of adverse events, deaths, and device deficiencies in accordance with relevant regulations and Medtronic's internal standards. This position is ideal for someone who values precision, teamwork, and the meaningful impact of maintaining patient safety in clinical research.

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

  • 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.

Required Knowledge and Experience: 

  • Practical knowledge and demonstrated competence within job area 
  • Bachelor's degree and a minimum of 2 years of relevant work experience
  • Fluency in English.

Prior work experience with Medtronic products and/or therapies would be a plus.

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. 

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.
 

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).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 95,000+ 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  
 

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