Medical Safety Analyst

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 Q