Senior Medical Safety Specialist
Arden Hills, MN, US, 55112
Additional Location(s): US-MN-Arden Hills; US-MA-Bedford; US-MA-Boston; US-MA-Burlington; US-MA-Cambridge; US-MA-Lexington; US-MA-Lowell; US-MA-Marlborough; US-MA-Natick; US-MA-Quincy; US-MA-Western/Springfield; US-MA-Worcester; 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:
This role manages surveillance processes across a wide range of Peripheral Interventions products and disease states such as Peripheral Artery Disease, Carotid Artery Disease, Venous Disease, Pulmonary Embolism, Malignant & Benign Tumors, Gastrointestinal Disease, Abscesses and more. 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. Major interfaces include:Clinical, Regulatory, Quality, Post Market Surveillance, Complaint Management Center and functional management. Performs work alongside Medical Safety colleagues and under supervision of the Medical Director/ Medical Safety Manager.
This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Arden Hills or Maple Grove, MN or Marlborough, MA. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.
Your responsibilities will include:
⦁ This role will provide medical support to the Medical Devices within Peripheral Interventions business (PI).
⦁ Applies knowledge and experience of clinical medicine to a wide range of PI products in one or more therapeutic areas.
⦁ Receives and analyzes data from multiple sources (clinical trials, complaints, Medical Device Reports, etc.), identifies potential safety issues, and participates in trend analysis.Provides accurate, succinct summaries at team and cross functional meetings.
⦁ Performs medical review and assessment for individual case safety reports, aggregate reports, literature, risk management and other required documents.
⦁ Represents Medical Safety at multi-functional team meetings such as complaint trend meetings.
⦁ Works closely with Analyst team, Medical Directors and Manager to produce clear and concise communication of complex data.
⦁ Escalates potential patient safety issue for decision-making and/or potential action by senior leadership.
⦁ Seeks opportunities for continuous quality improvement.
⦁ Applies working knowledge of medical device regulations and standards (globally).
Required qualifications:
⦁ Bachelor's level degree or equivalent in healthcare related field. Examples of health-related field professionals include registered nurse, physician’s assistant, and nurse practitioners.
⦁ Minimum of 5 years of direct patient care experience preferably in a hospital, interventional setting or outpatient surgical center.
⦁ Minimum of 5 years of experience in clinical/scientific research, preferably with medical devices and clinical trials
Preferred qualifications:
⦁ Post Market Surveillance experience in medical device industry preferred
⦁ Oncology or Vascular product experience preferred
⦁ Ability to think analytically and process scientific and medical data, with the ability to multi-task and problem solve
⦁ Must possess the ability to work and make independent decisions, understand complex medical information, and be able to take the initiative to lead projects and assignments
Requisition ID: 593171
Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement/ The foal 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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran’s status, age, mental or physical disability, genetic information or any other protected class.
Boston Scientific maintains a prohibited substance 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.
Nearest Major Market: Minneapolis
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