Senior Medical Safety Specialist at Medtronic in Louisville, Colorado
Posted in General Business 30+ days ago.
Type: Full-Time
Job Description:
SENIOR MEDICAL SAFETY SPECIALIST
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It's no accident -we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
Careers that Change Lives
The Senior Medical Safety Specialist is responsible for providing medical expertise and assessment to support patient safety throughout the lifecycle.
In this role your primary responsibility is providing technical and clinical information regarding product usage and performance, specifically as it relates to patient safety. You will collaborate with multiple functions including Research and Development, Risk Management, Quality/Post-Market Vigilance, Regulatory, and Clinical.
A Day in the Life
You will apply your medical knowledge, clinical expertise, and product knowledge to support patient safety through the application of:
Medical Knowledge and Experience:
- Maintain medical knowledge in medical specialties, diagnoses, treatments and procedures related to product and therapy areas.
- Leverage medical knowledge and advocate for patient safety by providing medical safety input to internal functions and business processes across the product life cycle where the Medical Safety role is defined.
- Evaluate events and potential safety signals identified through Quality, Clinical, and Regulatory related business unit processes.
- Author high quality and accurate safety assessments per business unit processes, leveraging complaint data, literature, registries, or other data sources as appropriate.
- Critically assess and escalate newly identified safety issues (suspected increase in severity and/or frequency of known events or new event with causal relationship to the device) per business unit processes for investigation assessment and action.
- Assist with obtaining input from external medical and subject matter experts on safety matters.
- Complete qualitative and quantitative assessments of post market adverse events, medical significance, and recommendations for inclusion in regulatory annual reports.
Product and Therapy Knowledge:
Business Acumen:
Medical Communication and Influence:
Must Have: Minimum Requirements
- Bachelors degree required
- Minimum of 4 years of clinical experience, or advanced degree with a minimum of 2 years clinical experience
- Licensed healthcare professional or certified personnel with clinical knowledge and relevant patient care experience.
Nice To Have
- Bachelor's degree or higher in a biologic science with preference towards healthcare or medical profession (e.g., nurse, nurse practitioner, physician assistant, or other related medical/scientific field).
- Solid medical background with the ability to understand complex disease states and different treatment outcomes and complications with a preference towards cranial/spinal surgical experience.
- Excellent verbal and written English communication skills
- Good understanding of regulatory guidance from European Medicines Evaluation Agency (EMEA), Food and Drug Administration (FDA).
- Proficient in Microsoft Office applications including Microsoft Word and Excel and ability to learn new document systems/solutions.
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
Physical Job Requirements
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. (ADA-United States of America)
Additional Information
- Posting Date: Nov 24, 2020
- Travel: No
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