Senior Safety Program Specialist

Additional Location(s):US-MA-Marlborough; US-MN-Minnetonka

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 Senior Safety Program Specialist manages adverse event, device reporting, and safety deliverables for investigational and marketed products in the Urology division. This position is responsible for authoring and ensuring execution of project-specific safety plans as well as overseeing event and complaint processing in accordance with study-specific operational plans.

Your responsibilities will include:

• Author study specific safety documents and plans (eg: safety plan, CEC/IMR Charter, etc.)
• Assess type/level of processing to be done for adverse events
• Manage adverse event processing including report review, safety query management, and expedited reporting
• Acting member of clinical core team
• Conduct Clinical Trial Safety Review meetings
• Ensure adjudication and reconciliation of safety events are completed prior to data snapshots
• Provide safety-related input to other study documents/processes as requested (eg: protocol, CRF design, etc.)
• Manage functional deliverables to ensure study milestones are not delayed
• Management of additional projects, deliverables, and timelines to support additional activities within the clinical department
• May perform medical review and assessment of adverse events in clinical trials

Required qualifications:

• 5 years clinical trial experience within role of Safety
• Therapeutic knowledge in Urology
• Strong analytical and problem-solving skills
• Knowledge of GCP
• Knowledge of medical terminology
• Excellent written and oral communication skills and high attention to detail

Preferred qualifications:

• Licensed healthcare professional or certified personnel with clinical knowledge and relevant direct patient care experience (e.g. CMA, RMA, CST, RN, MD, PA, NP)
• Experience with processing and assessing safety events and medical narrative writing
• Solid understanding of functional specialty
• Clinical database and systems experience
• Independently determines and develops approaches to solutions
• Excellent organization skills

Requisition ID:592455

Among other requirements, Boston Scientific maintains specific prohibited substancetesting 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 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.