Principal Medical Safety Specialist
Irvine, California, United States
Oct 13, 2019
PRINCIPAL MEDICAL SAFETY SPECIALIST
Careers That Change Lives
The Principal 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 Neuromodulation products and therapies.
The Principal MS Specialist is considered a safety expert for assigned therapy area(s) and works with limited oversight on more difficult and complex medical safety activities, in collaboration with MS team members and other functions, including Regulatory, Quality, Risk Management, Complaint Handling, Product Development, and Medical Affairs. The Principal MS Specialist may provide guidance and coaching to junior MS employees. The Principal MS Specialist represents the MS function on Medtronic cross-functional teams as a primary contact and interacts with senior internal and external customers, including expert physicians.
A Day In The Life
The individual will provide a range of medical services, including application of:
Medical Knowledge and Experience:
- Medical Input:
- Leverage medical knowledge and advocate for patient safety by providing expert medical safety input to internal functions and business processes across the product life cycle where role is defined by governing SOPs.
- Evaluate more complex, unique, or ambiguous 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.
Product and Therapy Knowledge:
- Acquire and maintain proficient knowledge of assigned products and therapies including device design and function, product labeling, indications, populations evaluated, diseases treated, mechanism of action, care pathways, and a deep understanding of safety profile, hazards, and harms.
- Actively acquire and maintain advanced 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.
- Actively provide strategic input to shape department and influence business strategies to optimize MS value.
- Proficient understanding of organization, functional roles and interactions, strong business insights and ability to work effectively across the matrix. Advanced understanding of key business processes involving MS (e.g., risk management, post market vigilance).
- Develop solutions and lead opportunities to advance and improve safety practices. May lead other projects as assigned in part or entirety that span outside of MS.
- Collaborate and develop trusted relationships with key functions; lead and influence evidence-based medical decision making across the matrix organization.
- Proficient ability to competently interpret, synthesize, and effectively communicate medical information across a variety of levels and audiences. Proactive ability to seek, include, and lead discussion of multiple perspectives in collaborative manner. Adapts communication style to situational context.
- Adaptable to changing priorities and work demands.
- Bachelor's degree in a biologic science
- Minimum 7 years of clinical experience Or minimum 5 years of clinical experience with an advanced degree.
- Licensed healthcare professional or certified personnel with clinical knowledge and relevant patient care experience.
- Degree preference towards healthcare or medical profession (e.g., nursing, medicine, pharmacy, biological science, or other related medical/scientific field).
- Proficient ability to understand and apply practical medical and product knowledge in a competent and consistent manner for Medical Safety activities.
- Proven ability to make competent, risk-based, and timely medical safety decisions based on insightful analysis of critical information; able to balance analysis with decisiveness.
- Proficient ability 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.
- Solid critical thinking and problem-solving skills.
- High attention to detail and accuracy; ability to work independently and mentor junior work colleagues; accountable for outcomes.
- Proven ability to develop trusted relationships and collaborate with co-workers and functional partners in a matrixed organization.
- 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.
- Proficient computer skills with experience in Microsoft Office Word, PowerPoint, and Excel.
- 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.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.