Safety Program Specialist

Additional Locations: Costa Rica-Coyol

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 Program Safety Specialist II is responsible for managing adverse events, device reporting, and safety deliverables for investigational and marketed products in the Rhythm Management division. This includes authoring and ensuring the execution of project-specific safety plans and overseeing event and complaint processing in accordance with study-specific operational plans.

Your responsibilities will include:

• Develop and author study-specific safety documents and plans (e.g., Safety Plan, Complaint Plan, CEC/IMR Charter).
• Assess the type and level of processing required for adverse events.
• Manage adverse event processing, including report reviews, safety query resolution, and expedited reporting.
• Perform medical review and assessment of adverse events in clinical trials.
• Participate as a core team member in clinical study teams.
• Lead Clinical Trial Safety Review meetings.
• Ensure adjudication and reconciliation of safety events prior to data snapshots, as applicable.
• Provide safety-related input for study documents and processes (e.g., protocol development, CRF design).
• Ensure timely delivery of functional safety outputs to support study milestones.
• Oversee additional projects and deliverables within and outside the department as needed.

Required Skills:

• Effective verbal and written communication skills.

• Strong analytical kills for identifying and addressing safety-related issues.
• Exceptional organizational and time management skills to prioritize tasks and meet deadlines.

Required qualifications:

• Bachelor’s degree (or equivalent) nursing, science or related field.
• Minimum of 3 years in clinical/scientific research, medical device, or clinical trials experience.

Preferred qualifications:

• Knowledge of device therapies in Electrophysiology, Watchman and Rhythm Management.
• Experience in processing and assessing safety events in clinical trials.
• Familiarity with Good Clinical Practice (GCP) guidelines.
• Knowledge of applicable safety regulations, including ISO 14155 and 21 CFR 812.

Requisition ID: 604108

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!