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Medical Safety Analyst
3 months ago
Additional Location(s): US-MN-Maple Grove; US-MN-Arden Hills; US-MN-Mankato/Rochester; US-MN-Minneapolis; US-MN-Minnetonka; US-MN-Northern/Duluth; US-MN-Plymouth
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.
**This role requires thrice a week office presence in our Boston Scientific Arden Hills, MN location **
About the role:
The Medical and Clinical Safety Analyst is responsible for providing medical oversight across a range of products, services, and disease states in cardiac diagnostic services within rhythm management, including non-implantable cardiac monitoring devices. This health care professional collaborates directly with Medical Directors and other team members cross-functionally to provide medical input and oversight throughout the product lifecycle as an advocate for patient safety. Medical Support will also be provided to two Medicare-enrolled Independent Diagnostic Testing Facilities (IDTFs) where qualified lab personnel are available 24/7 to provide the technical component of the remote diagnostic monitoring services in accordance with the ordering provider's event, notification and delivery protocols, and applicable payor guidelines and requirements.
This safety role uses subject matter expertise (practical medical and device knowledge) and clinical evidence to support Medical Director(s) and Medical Vice President in delivery of timely, accurate, and well-grounded medical safety perspective.
Your responsibilities will include:
⦁ Makes thoughtful, risk-based and timely medical safety decisions.
⦁ Applies medical experience/product knowledge and critical thinking to support daily medical safety responsibilities.
⦁ Performs medical review and assessment of adverse events, sources of which include but are not limited to clinical trials, complaints and Medical Device Reports (MDRs).
⦁ Identifies potential safety signals for monitoring and trend analysis. Represents Medical Safety in associated cross-functional and cross-divisional meetings.
⦁ Maintains deep understanding and ongoing proficiency of applicable products/therapies to assess potential risks and provide timely medical input to cross-functional teams. Note: support of specific product families may require enhanced technical expertise of both product and supporting systems.
⦁ Performs pre-scheduled and ad hoc analyses of data from multiple sources and presents data by communicating accurate, succinct summaries at team and cross-functional meetings.
⦁ Based on solid understanding of product design and use, provides input to product labeling in collaboration with cross-functional teams.
⦁ Applies working knowledge of medical device regulations and standards (globally).
⦁ Develops a solid network across the functions and divisions to support Medical Safety's collaboration with key functional stakeholders.
⦁ Effectively escalates potential patient safety issues for decision-making and/or potential action by senior leadership.
⦁ Medical Support of IDTF includes:
⦁ Supports the IDTF Medical Directors and the IDTF training and Medical Safety teams in planning and delivering the appropriate training of IDTF non-medical personnel
⦁ Supports the IDTF technicians and Medical Safety team in the process of event escalation and review, and may help with further escalation to the IDTF Medical Director, ensuring timeliness and sense of urgency depending on the event's nature while in compliance with the protocols established by the relevant medical facility
Required qualifications:
⦁ Minimum of 8 years of clinical experience with particular focus in cardiology/electrophysiology
⦁ Allied Health Professional preferred (PA, NP)
⦁ Healthcare Licensure/Certification
⦁ Recent clinical experience in cardiovascular patient care, including but not limited to advanced ECG rhythm interpretation, arrhythmia management, remote cardiac monitoring, telemetry, and implantable cardiac diagnostic devices (i.e., ILR).
⦁ Minimum of 2 years of direct patient care experience, cardiac specific (ie: CCU, Cath Lab, EP Lab, cardiology practice)
⦁ Advanced knowledge of cardiac patient management, remote cardiac monitoring, telemetry, arrhythmia management.
Preferred qualifications:
⦁ Prior related work experience in Medical Safety, Clinical Research, and/or Clinical Quality
⦁ Prior experience with safety monitoring in medical device industry
⦁ Demonstrated success in collaborating with and communicating effectively across different functions
⦁ Master's degree in healthcare/clinical research related field preferred
Requisition ID: 586774
Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § , Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.
