Safety Program Specialist jobs at Boston Scientific in Costa Rica, El Amparo
Boston Scientific Safety Program Specialist Costa Rica, Alajuela Province, El Amparo
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Costa Rica-Coyol
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.
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!
These jobs might be a good fit
Share
Costa Rica-Coyol
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.
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!
These jobs might be a good fit
