At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all.
Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
As 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 Medtronics 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
Bachelors 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 ***** 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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