[Hiring] Senior Medical Safety Specialist @MiniMed

Role Description

The Senior Medical Safety (MS) Specialist will be primarily responsible for providing technical and clinical information regarding product usage and performance, specifically as it relates to patient safety. The Senior MS Specialist will collaborate with multiple functions including Research and Development, Risk Management, Quality/Post-Market Vigilance, Regulatory, and Clinical to help deliver against our highest quality standards.

• Apply medical knowledge, clinical expertise, and product knowledge to support patient safety.

Medical Knowledge and Experience

• 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.
• 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 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.

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.
• Knowledgeable 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 MSO 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.
• 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.

Qualifications

• Licensed healthcare professional or certified personnel with clinical knowledge and relevant patient care experience (e.g., RN, MD, PA, NP).
• Bachelor’s degree with a minimum of 4 years of Clinical Experience in Diabetes, Medical Safety/Medical Affairs, or an advanced degree with a minimum of 2 years of experience in Diabetes, Medical Safety/Medical Affairs.

Requirements

• Experience managing clinical research complaints and safety events in global regulatory studies.
• Combination of Licensure and Medical Affairs/Safety or Clinical Management experience.
• Five or more years in the Medical Device Industry.
• 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 understand scientific/technical concepts and the function of medical devices.
• Able to effectively communicate verbally and in writing, and effectively influence diverse stakeholders.
• 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, accountable for outcomes.
• Able to develop trusted relationships and collaborate with co-workers and key functional partners.
• Good understanding of regulatory guidance from the European Medicines Evaluation Agency (EMEA), and the Food and Drug Administration (FDA).
• Proficient in Microsoft Office applications including Microsoft Word and Excel.

Benefits

• Competitive salary and flexible benefits package.
• Health, dental, and vision insurance.
• Access to a Health Savings Account and Healthcare Flexible Spending Account.
• Life insurance and long-term disability leave.
• Dependent daycare spending account.
• Incentive plans and a 401(k) plan with company match.
• Short-term disability coverage and paid time off.
• Participation in the Employee Stock Purchase Plan and access to the Employee Assistance Program.
• Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements.