About the role:
The Principal Medical Safety Specialist is a health care professional responsible for the medical review of adverse event data across a range of products and disease states in cardiology. This individual completes accurate, timely and consistent medical assessments of adverse events and potential adverse events to provide medical expertise and objective oversight and help ensure safety vigilance throughout the total product lifecycle.
This role performs medical assessments of adverse events, evaluates emerging safety signals and product performance trends, and provides clinical input into risk management, post-market surveillance and patient safety decisions. As a Medical Safety subject matter expert, this individual partners closely with the Medical Director and cross-functional teams across Quality, Regulatory, Clinical, R&D, Medical Affairs and Commercial functions to evaluate complex safety issues and support informed benefit-risk and patient safety decisions.
Responsibilities will include:
- Serve as a Medical Safety subject matter expert on cross-functional teams supporting product development, risk management, post-market surveillance, quality investigations and remediation activities.
- Apply advanced clinical and technical knowledge of cardiology to assess device safety, product performance and potential patient impact.
- Perform medical review and assessment of adverse events and potential adverse events from clinical trials, post-market complaints, Medical Device Reports (MDRs) and other relevant data sources.
- Lead the evaluation of complex or emerging safety signals, trends and product performance concerns, providing clinical assessments and recommending appropriate escalation or risk mitigation.
- Provide medical expertise for complaint review boards, corrective and preventive actions (CAPAs), nonconforming event processes (NCEPs), product investigation reports (PIRs) and other applicable quality system processes.
- Analyze data from multiple sources and communicate concise, clinically meaningful safety assessments and recommendations to the Medical Director, cross-functional teams and leadership.
- Acquire and maintain proficient knowledge of assigned products and therapies, including device design and function, product labeling, indications, mechanisms of action, care pathways and overall safety profiles, including hazards and harms.
- Provide medical review and input for risk management documentation, labeling, instructions for use (IFUs), product safety communications, post-market surveillance and regulatory deliverables.
- Review promotional, educational and sales training materials for medical and clinical accuracy, as applicable.
- Identify opportunities to improve Medical Safety processes and practices.
- Apply knowledge of applicable global medical device regulations, standards and reporting requirements.
Qualifications:
Required qualifications:
- Bachelor's or advanced degree in health care, life sciences or related field.
- Active, unencumbered professional licensure as a registered nurse (RN), Doctor of Nursing practice (DNP) or physician assistant (PA).
- Minimum of 5 years of direct patient care experience, including a minimum of 3 years of cardiac lab experience.
- Experience with Microsoft 365.
- Proven ability to work independently and autonomously.
- Strong clinical judgment and analytical skills, with the ability to interpret complex medical, scientific and product performance information.
- Demonstrated ability to make sound independent decisions, navigate ambiguity, manage competing priorities and lead complex work with minimal supervision.
- Excellent technical writing and verbal communication skills, with the ability to clearly communicate complex clinical and safety information.
- Demonstrated ability to build effective cross-functional relationships and influence without formal authority.
Preferred qualifications:
- Minimum of 2 years of related experience in Medical Safety within the medical device industry, Risk Management, Clinical Research and/or Clinical Quality.
- Recent industry experience.
- Medical device experience.