Principal Medical Safety Specialist Job

Additional Location(s): N/A

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.

About the role:

The Principal Medical Safety Specialist is responsible for providing medical oversight across a range of products and disease states in electrophysiology and rhythm management, including diagnostic and therapeutic cardiac electrophysiology and cardiac implantable electronic devices.

This health care professional collaborates directly with the Medical Director(s) and other team members cross-functionally to provide medical input and oversight throughout the product lifecycle as an advocate for patient safety. Uses subject matter expertise (practical medical and device knowledge) and clinical evidence to support Medical Director(s) and Vice President of Medical Safety in delivery of timely, accurate, and well-grounded medical safety perspective.

On-site preferred, but remote option would be considered to sit anywhere in the U.S.

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 in order 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.

Required Qualifications:

• Bachelor’s degree in healthcare/life science related field
• 8 years of clinical or related experience
• Minimum of 2 years of direct patient care experience, cardiac specific (ie: CCU, Cath Lab, EP Lab)
• Healthcare Licensure/Certification (RN, NP, PA)
  

Preferred Qualifications:

• Recent clinical experience in the EP Lab: arrhythmia mapping and ablation procedures, pacemaker implants, ICD implants.
• Advanced knowledge of cardiac implantable device management and programming
• IBHRE Certification: CCDS and/or CEPS
• Related work experience in Medical Safety, Clinical Research, and/or Clinical Quality
• Knowledge/Experience with Clinical Trials (ie: research coordinator, research participation in practice)
• Experience with safety monitoring in medical device industry
• Demonstrated success in collaborating with and communicating effectively across different functions
• Master’s in healthcare/clinical research related field

Requisition ID: 518111

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 drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), 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.