Medical Safety Spec

MiniMed•Los Angeles, CA

3d•$68,000 - $116,000

About The Position

The Medical Safety (MS) Specialist is responsible for providing medical expertise and assessment to support patient safety throughout the lifecycle as both an advocate for patient safety and in support of safe and effective use of Diabetes products and therapies. With general supervision, the MS Specialist works on a range of medical safety activities of varying complexity in collaboration with MS team members and other functions, including Risk Management, Quality/ Post-Market Vigilance, Research & Development, Regulatory, and Clinical. The MS Specialist primarily interacts with MS personnel, with other functions as needed to share information or gain input to support decision making. The MS Specialist will apply medical knowledge, clinical expertise, and product knowledge support to patient safety through the application of: Medical Input: Basic understanding of practical medical/scientific concepts. General knowledge in medical specialties, diagnoses, treatments, and procedures related to product and therapy area. Basic understanding of how to search medical/scientific databases and evaluate literature. Leverage medical knowledge and advocate for patient safety by providing medical safety input to internal functions and business processes across the product life cycle where the Medical Safety role is defined. May be involved in cross-functional assignments. Medical Safety Assessments: Evaluate events and potential safety signals identified through Quality, Clinical, and Regulatory related business unit processes. Author high-quality and accurate safety assessments per business unit processes, leveraging complaint data, literature, registries, or other data sources as appropriate. Critically assess and escalate newly identified safety issues (suspected increase in severity and/or frequency of known events or new events with a causal relationship to the device) per business unit processes for investigation assessment and action. Assist with obtaining 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 therapy and knowledge: Basic understanding of supported therapy indications and relevant disease states. Understands product design and use, basic mechanism of action, product labeling, and general safety profile. Business Acumen: Basic understanding of key medical device lifecycle processes. Knowledge of governing regulations and key industry practices related to the function. General awareness of organizational design, functional roles, and key business strategies. Aware of and contributes to the Medical Safety Function strategy success. Medical Communication and Influence: Basic ability to interpret, synthesize, write, and present medical information in an accurate and logical manner. Interacts primarily and effectively with internal peers. External interactions are less complex or problem solving in nature. May provide guidance and assistance to entry level professionals and /or employees in the support career stream. Adapt verbal and written communication style to situational context. Adapt to changing priorities and work demands.

Requirements

Licensed healthcare professional or certified personnel with clinical knowledge and relevant patient care experience (e.g., RN, RD, MD, PA, NP).
Bachelor’s degree with a minimum of 2 years of Clinical Experience in Diabetes, Medical Safety/Medical Affairs, or an advanced degree with a minimum of 1 year of experience in Diabetes, Medical Safety/Medical Affairs.

Nice To Haves

Basic ability to understand and apply practical medical and product knowledge in a competent manner for Medical Safety activities.
Able 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.
Able to effectively communicate verbally and in writing, and effectively influence diverse stakeholders (team members, functional partners, and HCPs).
Solid medical background with the ability to understand complex disease states and different treatment outcomes and complications.
Versatile learner, able to quickly and effectively integrate new information and skills.
Solid critical thinking and problem-solving skills.
High attention to detail and accuracy; able to work independently with general supervision; accountable for outcomes.
Able to develop trusted relationships and collaborate with co-workers and key functional partners.
Excellent verbal and written communication skills.
CDCES, Certified Diabetes Care and Education Specialist.

Responsibilities

Provide medical expertise and assessment to support patient safety throughout the lifecycle.
Act as an advocate for patient safety and support the safe and effective use of Diabetes products and therapies.
Work on a range of medical safety activities of varying complexity in collaboration with MS team members and other functions.
Evaluate events and potential safety signals identified through Quality, Clinical, and Regulatory related business unit processes.
Author high-quality and accurate safety assessments per business unit processes.
Critically assess and escalate newly identified safety issues per business unit processes for investigation, assessment, and action.
Assist with obtaining 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.
Provide evidence-based medical safety input, education and/or response to safety inquiries from internal or external stakeholders.
Leverage medical knowledge and advocate for patient safety by providing medical safety input to internal functions and business processes across the product life cycle.
May be involved in cross-functional assignments.
Provide guidance and assistance to entry level professionals and /or employees in the support career stream.