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Engineering the extraordinary
Senior Medical Safety Specialist
Location
United States
Posted
91 days ago
Salary
$107K - $160K / year
Seniority
Senior
Job Description
Senior Medical Safety Specialist
Medtronic
We anticipate the application window for this opening will close on - 27 Mar 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Position can be remote in the United States. The Senior Medical Safety Specialist is responsible for providing medical expertise and assessment to support patient safety throughout the product lifecycle. The position is primarily responsible for providing technical and clinical information regarding product usage and performance, specifically as it relates to patient safety. You will collaborate with multiple functions including Research and Development, Risk Management, Quality/Post-Market Vigilance, Regulatory, and Clinical. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. You will apply your medical knowledge, clinical expertise, and product knowledge to support patient safety through the application of: Medical Input: • Maintain medical knowledge in medical specialties, diagnoses, treatments and procedures related to product and therapy areas. • 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. 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 and Therapy Knowledge: • Acquire and maintain proficient knowledge of assigned products and therapies, such as device design and function, product labeling, indications, mechanism of action, care pathways, and overall safety profile (i.e., hazards and harms). • Actively acquire and maintain knowledge of relevant scientific literature associated with assigned devices/therapies. Business Acumen: • Acquire and maintain advanced knowledge of applicable business unit policies/procedures, and relevant regulatory requirements and guidelines (e.g., ISO 14971, Application of Risk Management, ISO 13485, Quality Management Systems). • Maintain an advanced understanding of key business processes involving Medical Safety (e.g., risk management, post market vigilance). • Work effectively across the matrix • Develop solutions and lead opportunities to advance and improve safety practices. May lead other projects as assigned in part or in entirety that span outside of Medical Safety. Medical Communication and Influence: • Lead and influence evidence-based medical decision making across the matrix organization. • Provide strategic input and influence business strategies to optimize Medical Safety value. • Interpret, analyze, and effectively communicate medical assessment across a variety of levels and audiences. • Adapt verbal and written communication style to situational context. • Adapt to changing priorities and work demands. ** There will be up to 10% travel for this position. Minimum Requirements • 4+ years of clinical experience (2+ years with an advanced degree). • Active healthcare license with clinical knowledge and relevant patient care experience. • Bachelor’s degree or higher in a biologic science with preference towards healthcare or medical profession (e.g., nurse, nurse practitioner, physician assistant, or other related medical/scientific field). Nice to Have • Solid medical background with the ability to understand complex disease states and different treatment outcomes and complications with a preference towards cranial and/or spinal surgical specialty experience. • Excellent verbal and written English communication skills • Good understanding of regulatory guidance from European Medicines Evaluation Agency (EMEA), Food and Drug Administration (FDA). • Proficient in Microsoft Office applications including Microsoft Word and Excel and ability to learn new document systems/solutions. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 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. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$107,200.00 - $160,800.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. 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. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Job Requirements
- 4+ years of clinical experience (2+ years with an advanced degree).
- Active healthcare license with clinical knowledge and relevant patient care experience.
- Bachelor’s degree or higher in a biologic science with preference towards healthcare or medical profession.
- Solid medical background with the ability to understand complex disease states and different treatment outcomes and complications.
- Excellent verbal and written English communication skills.
- Good understanding of regulatory guidance from European Medicines Evaluation Agency (EMEA), 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.
- Health Savings Account.
- Healthcare Flexible Spending Account.
- Life insurance, Long-term disability leave.
- Dependent daycare spending account.
- Tuition assistance/reimbursement.
- Incentive plans, 401(k) plan plus employer contribution and match.
- Short-term disability.
- Paid time off.
- Paid holidays.
- Employee Stock Purchase Plan.
- Employee Assistance Program.
- Non-qualified Retirement Plan Supplement.
- Capital Accumulation Plan (available to Vice Presidents and above).
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Sarah Cannon Research InstituteSarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. SCRI’s research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S.
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Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates. McKesson job postings are posted on our career site: careers.mckesson.com. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
It’s More Than a Career, It’s a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. 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Prime TherapeuticsEstablished in 1988, Prime Therapeutics helps people get the medicine they need to manage their health. This company manages pharmacy coverage for patients thro
At Prime Therapeutics (Prime), we are a different kind of PBM, with a purpose beyond profits and a unique ability to connect care for those we serve. Looking for a purpose-driven career? Come build the future of pharmacy with us. Job Posting Title Pharmacy SIU Investigator - RemoteJob Description The Special Investigations Unit (SIU) Investigator is responsible for conducting standard investigations of potential pharmacy, member, and/or prescriber fraud, waste and abuse (FWA). This position conducts claims data mining, fraud analysis and auditing/monitoring activities and proactively identifies improvement opportunities in investigation procedures and FWA prevention efforts ensure proper identification of potential FWA. The SIU Investigator prepares investigative reports for leadership, remediation actions, recovery efforts, internal committees and/or referral to state and federal law enforcement agencies. Responsibilities - Develop investigative plans, documents and justification to support investigations; evaluate impact of changing circumstances or newly discovered evidence to a previously developed investigation plan; proactively communicate plans, progress and changes to department leadership and other internal or external stakeholder - Obtain and review factual and reliable evidence to support investigative outcomes; evidence reviews may include invoice documentation, entity interviews, background checks, pharmacy documentation, licensing information, proof of delivery and payment level information - Evaluate reports of potential fraud in SIU and make recommendations on next steps; ensure investigative action aligns to department policy and practice; provide recommendations to audit operations and/or SIU regarding enhancements or required changes to process - Adhere to evidentiary requirements in compliance with federal, state and local laws pertaining to investigations and fair claims handling practices; evaluate risk to determine how best to proceed with investigations based on the allegations, quality metrics and other performance indicators required per SIU procedures - Recommend referrals to client SIUs, regulatory agencies, and/or law enforcement; recommend retention of experts or private investigators, surveillance or other expenditures to support investigations - Other duties as assigned Minimum Qualifications - Bachelor's degree in Criminal Justice, Healthcare or related area of study or the equivalent combination of education and relevant work experience; HS diploma or GED is required - 2 years of work experience in investigation, audit, healthcare or legal Must be eligible to work in the United States without the need for work visa or residency sponsorship Additional Qualifications - Change agile with a willingness and ability to adjust direction based upon changing priorities and business need while working with a high degree of autonomy - Ability to think critically, problem solve and use appropriate judgement to make decisions and provide risk advice to internal and external partners while anticipating the broad impact of decisions - Ability to establish trust, respect and credibility and form effective working relationships with individuals at all levels of an organization; collaborate effectively cross-functionally and with clients, law enforcement and other key stakeholders - Ability to distill complex concepts or situations into concise and compelling communications - Knowledge and understanding of pharmacy and medical claims processing environment Preferred Qualifications - Certified Fraud Examiner (CFE) or Accredited Health Care Fraud Investigator (AHFI) - National Pharmacy Technician Certification through PTCB or ExCPT (CPhT) - Licensed Practical Nurse (LPN) or Registered Nurse (RN) - Experience working with RxClaims and/or JUDI - Previous audit and investigation experience - Pharmacy background within retail, mail order, hospital, or compounding setting - Data mining experience - Excel experience Every employee must understand, comply with and attest to the security responsibilities and security controls unique to their job, and comply with all applicable legal, regulatory, and contractual requirements and internal policies and procedures Every employee must be able to perform the essential functions of the job and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions, absent undue hardship. In addition, Prime retains the right to change or assign other duties to this job. Potential pay for this position ranges from $59,000.00 - $94,000.00 based on experience and skills. To review our Benefits, Incentives and Additional Compensation, visit our Benefits Page and click on the "Benefits at a glance" button for more detail (https://www.primetherapeutics.com/benefits). Prime Therapeutics LLC is proud to be an equal opportunity and affirmative action employer. We encourage diverse candidates to apply, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sex (including pregnancy), national origin, disability, age, veteran status, or any other legally protected class under federal, state, or local law. We welcome people of different backgrounds, experiences, abilities, and perspectives including qualified applicants with arrest and conviction records and any qualified applicants requiring reasonable accommodations in accordance with the law. Prime Therapeutics LLC is a Tobacco-Free Workplace employer. Positions will be posted for a minimum of five consecutive workdays.



