Senior Medical Safety Specialist

Additional Location(s): US-MA-Marlborough; US-AL-Birmingham; US-AR-Little Rock; US-CT-Hartford; US-CT-New Haven; US-CT-Stamford; US-DC-Washington; US-DE-Delaware; US-FL-Ft. Lauderdale; US-FL-Miami; US-FL-Orlando; US-FL-St. Petersburg; US-FL-Tallahassee; US-FL-Tampa; US-GA-Atlanta; US-IL-Chicago; US-IL-Southern; US-IN-Indianapolis; US-KS-Overland Park; US-KY-Louisville; US-LA-New Orleans; US-MA-Bedford; US-MA-Boston; US-MA-Burlington; US-MA-Cambridge; US-MA-Lexington; US-MA-Lowell; US-MA-Natick; US-MA-Quincy; US-MA-Western/Springfield; US-MA-Worcester; US-MD-Baltimore; US-ME-Central/Augusta; US-ME-Northern/Bangor; US-ME-Southern/Portland; US-MI-Detroit; US-MI-Grand Rapids; US-MN-Arden Hills; US-MN-Mankato/Rochester; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Minnetonka; US-MO-Kansas City/Independence; US-MO-St. Louis; US-NC-Charlotte; US-NC-Greensboro; US-NC-Raleigh/Durham; US-NH-Northern; US-NH-Southern; US-NJ-Central; US-NJ-Northern; US-NJ-Southern; US-NY-Albany/Poughkeepsie; US-NY-Buffalo; US-NY-New York City; US-NY-Rochester/Pittsford; US-NY-Syracuse; US-OH-Cincinnati; US-OH-Cleveland; US-OH-Columbus/Zanesville; US-PA-Erie; US-PA-Philadelphia; US-PA-Pittsburgh; US-PA-Wilkes Barre; US-RI-Providence; US-TN-Knoxville; US-TN-Memphis; US-TN-Nashville; US-VA-Charlottesville/Harrisonburg; US-VA-Fairfax; US-VA-Norfolk/Hampton Roads; US-VA-Northern; US-VT-Northern; US-VT-Southern; US-WI-Madison; US-WI-Milwaukee

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:
Responsible for medical review of adverse event data across a range of products and disease states in Interventional Cardiology. Completes accurate, timely, and consistent medical assessment of adverse events and potential adverse events in order to provide medical expertise, objective oversight and ensures safety vigilance throughout the total product lifecycle. This health care professional collaborates directly with Medical Directors.

Your responsibilities will include:

• Escalates potential patient safety issue for decision-making and/or potential action by senior leadership.
• Represents Medical Safety at multi-functional team meetings, such as and complaint trend and risk management meetings.
• Collaborates closely with internal Medical Directors, clinical trial managers, safety trial operations, and other Medical Safety Specialists as part of clinical project core teams.
• Identifies potential safety signals for monitoring and trend analysis.
• Performs medical review and assessment adverse events, sources of which include but are not limited to clinical trials, complaints, and Medical Device Reports (MDRs).
• 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.
• Uses knowledge and experience of clinical medicine to understand and evaluate the interface of medical devices to patients and users. Note: support of specific product families may require enhanced technical expertise of both product and supporting systems.
• Applies working knowledge of medical device regulations and standards (globally).

Required qualifications:

• Bachelor’s degree required in healthcare/life science related field. Examples of healthcare/life science related field include but are not limited to registered nurse, physician’s assistant, and nurse practitioners.
• 5+ years of professional experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials.

Preferred qualifications:

• Master’s in healthcare/life science related field. Examples of healthcare/life science related field include but are not limited to registered nurse, physician’s assistant, and nurse practitioners.
• Direct patient care experience or experience in healthcare setting
• Clinical experience in interventional cardiology and procedures
• Demonstrated success in collaborating with and communicating effectively across different functions
• Experience in operational safety within clinical studies
  

Requisition ID: 558853

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.