The Sr. Medical Safety (MS) Specialist has primary responsibility to provide medical input across the product lifecycle as an advocate for patient safety and in support of safe and effective use of Mazor Robotics products.
The Sr. MS Specialist works with limited oversight on a range of medical safety activities of varying complexity. The Sr. MS Specialist represents the MS function on Medtronic cross-functional teams.
Key Responsibilities & Authorities:
The individual will provide a range of medical services, including application of:
Medical Knowledge and Experience:
• Medical Input:
-Maintain medical knowledge in medical specialties, diagnoses, treatments and procedures related to assigned therapy area(s).
-Leverage medical knowledge and advocate for patient safety by providing competent and consistent medical safety input to internal functions and business processes across the product life cycle where role is defined by governing SOPs.
• Medical Safety Assessments:
-Evaluate adverse events or potential safety signals identified through data trending, complaint evaluation/investigation processes, and CAPA.
-Conduct effective and discerning research (literature, other data sources) and author high quality, accurate, and sound safety assessments.
-Critically assess and escalate newly identified safety issues (suspected increase in severity and/or frequency of known events or new event with causal relationship to the device) per governing process for investigation assessment and action.
-Facilitate input from external medical and subject matter experts on safety matters.
-Complete qualitative and quantitative assessments of post market adverse events, medical significance, and recommendations for inclusion in regulatory annual reports.
• Safety Inquiries:
Provide evidence-based medical safety input, education and/or response to safety inquiries from internal or external stakeholders (e.g., external medical personnel or other third-parties, including regulatory agencies or health care organizations).
Product and Therapy Knowledge:
•Acquire and maintain advanced knowledge of assigned products and therapies including device design and function, product labeling, indications, populations evaluated, diseases treated, mechanism of action, and care pathways, and advanced understanding of safety profile, hazards, and harms.
•Acquire and maintain knowledge of scientific literature regarding safety information associated with assigned therapies.
•Acquire and maintain advanced knowledge of relevant policies/procedures, regulations, and guidelines, including ISO 14971 (Risk Management) and FDA guidelines for classifying and reporting medical device and drug adverse events.
•Provide input to department strategy and understand business strategies.
•Advanced understanding of organization, functional roles and interactions, and working across the matrix. Solid understanding of key business processes (e.g., risk management, post market vigilance).
•Recommend and lead opportunities to improve safety practices. May lead other projects as assigned in part or entirety.
Medical Communication and Influence:
•Collaborate and develop trusted relationships with key functions; drive and influence evidence-based medical decision making across the matrix organization.
•Advanced ability to competently interpret, synthesize, and effectively communicate medical information to a variety of audiences.
•Adaptable to changing priorities and work demands
Bachelor’s degree or higher and RN or MD
5+ years of clinical experience Or Master’s degree and 2+ years of clinical experience.
Sspecialized Knowledge Required
•Advanced ability to understand and apply practical medical and product knowledge in a competent and consistent manner for Medical Safety activities.
•Advanced ability to make competent, risk-based, and timely medical safety decisions based on insightful analysis of critical information; able to balance analysis with decisiveness.
•Able to understand scientific/technical concepts and function of medical devices.
•Proven ability to effectively communicate verbally and in writing, and effectively influence diverse stakeholders (team members, functional partners, and HCPs).
•Experience writing medical reports on complex medical data/information.
•Industry experience in a Medical Device or Pharmaceutical Company, in Safety, Medical Affairs, Drug Information, Clinical Research, Clinical Quality, Regulatory, or related discipline.
•Work experience in neurological diseases, pain management, infusion technology, or clinical risk management.
•Strong knowledge of industry standards as well as all applicable laws and regulations
•Experience writing medical publications.
•Epidemiology/statistics education and application.
•Advanced knowledge of MedDRA coding.
Minimum travel required – approximately 10%.