Senior Medical Safety Specialist

About the role:

The Senior Medical Safety Specialist is a health care professional responsible for medical review of adverse event data across a range of products and disease states in cardiology/electrophysiology/LAAO. They will complete accurate, timely, and consistent medical assessments of adverse events and potential adverse events in order to provide medical expertise, objective oversight and ensure safety vigilance throughout the total product lifecycle. This health care professional collaborates directly with Medical Directors.

Responsibilities:

• Provides medical expertise and assessment to support patient safety throughout the product lifecycle.
• Provides technical and clinical information regarding product usage and performance, specifically as it relates to patient safety.
• Uses knowledge and experience of clinical medicine to understand and evaluate the safety of our devices for patient use
• • Note: support of specific product families may require enhanced technical expertise of both product and supporting systems, specifically electrophysiology lab procedures and disease states.
• 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.
• Collaborates with multiple functions including Research and Development, Risk Management, Quality/Post-Market Surveillance, Regulatory, and Clinical Research.
• 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.
• Represents Medical Safety at multi-functional team meetings, such as complaint trend meetings.
• Escalates potential patient safety issue for decision-making and/or potential action by senior leadership.
• Acquires and maintains proficient knowledge of assigned products and therapies, such as device design and function, product labeling, indications, mechanism of action, care pathways, and overall safety profile (i.e. hazards and harms).
• Applies working knowledge of medical device regulations and standards (globally).

Required Qualifications:

• Bachelor’s or advanced degree in healthcare/life science related field
• Active (unencumbered) licensure as an RN, DNP or PA
• 4+ years of direct patient care experience, 2+ years electrophysiology lab experience (i.e. preferred experience with PFA ablation and LAAO procedures)
• Experience with Microsoft office 365
• Proven ability to work independently and autonomously

Preferred Qualifications:

• 2+ years of related work experience in Medical Safety, Risk Management, Clinical Research and/or Clinical Quality
• Recent Industry experience
• Medical device experience