- Utilize knowledge and experience of clinical medicine to understand and evaluate the safety of our devices for patient use
- 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.
- Contributes to clinical trial safety planning and preparation, including safety related input to study document/processes as requested (eg: Protocol, Informed Consent, CRF design, etc)
- 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 for both investigational and marketed products
- Escalates potential patient safety issue for decision-making and/or potential action by senior leadership.
- Applies working knowledge of medical device regulations and standards (globally).
- Minimum Bachelor's degree in healthcare/life science related field
- Active licensure as an RN, DNP or PA
- 2+ years of direct patient care experience in cardiology
- Recent procedural electrophysiology lab experience; ablation focus
- 2+ years of related work experience in Medical Safety, Clinical Research and/or Clinical Quality
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Senior Patient Safety Specialist - Arden Hills, United States - Boston Scientific
Description
Additional Location(s): US-MN-Arden Hills; US-MN-Mankato/Rochester; US-MN-Maple Grove; 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.
About this role:
The Senior Patient Safety Specialist is responsible for medical review of adverse event data across a range of investigational and marketed products and disease states in cardiology/electrophysiology. Completes accurate, timely, and consistent medical assessment of adverse events and potential adverse events in order to provide medical expertise, objective oversight and safety vigilance throughout the total product lifecycle.
Your responsibilities may include:
Required qualifications:
Preferred qualifications:
Requisition ID: 583360
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.
