Medical Safety Manager - EI

Philips

United States of America, WA

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JOB DETAILS

SALARY

$133,000–$212,000 Per Year

SKILLS

Biotech and Pharmaceutical, Clinical Assessment, Clinical Competency, Clinical Data Management, Clinical Nursing, Clinical Practices/Protocols, Clinical Trial, Communication Skills, Compensation and Benefits, Cross-Functional, Data Analysis, Early Intervention, Environmental Work, Health Informatics, Healthcare, Healthcare Providers, Healthcare Quality, ISO (International Organization for Standardization), Identify Issues, Informatics, International Electro-Technical Commission (IEC), Interoperability, Maintain Compliance, Marketing, Medical Equipment, Medical Products, Medical Protocols, Nursing, Patient Care, Patient Safety, Pharmacovigilance, Problem Solving Skills, Product Lifecycle, Product Safety, Product/Service Launch, Regulations, Regulatory Compliance, Regulatory Submissions, Reimbursement, Risk Analysis, Risk Management, Safety Compliance, Standards of Care, Stock Purchase Plans, Surveillance

LOCATION

United States of America, WA

POSTED

Today

**Medical Safety Manager, Enterprise Informatics** The Enterprise Informatics Business portfolio connects clinical informatics, data management, and interoperability to deliver improved clinical insights to health care providers. The Medical Safety Manager, Enterprise Informatics (EI) responsible for conducting comprehensive evaluations of safety information sourced form a variety of channels such as Post-Marketing Surveillance (PMS) and literature searches, working under limited supervision. **Your role:** + Provides essential support in bolstering patient safety by actively contributing insights and recommendations to critical processes such as Risk Management, Health Hazard Evaluations (HHE), Risk-Benefit analyses, and recall procedures. + Offers valuable assistance in delivering safety-related perspectives for New Product Introduction (NPI) projects, clinical studies, and Post-Marketing Surveillance (PMS) efforts, facilitating informed decision-making. + Collaborates effectively to furnish pertinent safety inputs for regulatory submissions and key documents such as Risk-Benefit Analyses (RBA), protocols, Clinical Study Reports (CSR), and Clinical Evaluation Reports (CERs), ensuring compliance and transparency in safety evaluations. + Conducts literature reviews and surveillance activities to identify emerging safety issues, ensuring initiative-taking identification and mitigation of potential risks. Provides answers to safety-related inquiries from healthcare professionals, patients, and internal stakeholders, fostering trust and transparency in communication regarding product safety. + Contributes to the implementation of safety-related policies, procedures, and programs to promote a culture of safety and compliance within the organization. Maintains awareness of evolving regulations and guidelines related to medical product safety and ensures compliance with applicable requirements. + Provides input into the design and conduct of safety studies and medical device vigilance activities to ensure robust safety surveillance throughout the product lifecycle. + Analyzes safety data from clinical trials and post-market surveillance to identify potential safety signals and trends, facilitating early detection and intervention for improving patient safety. **You're the right fit if:** + You've acquired 7+ years of experience in areas such as Medical/Clinical affairs in Medical Device/Biotech industry or equivalent. You must have an active clinical license (Nursing or MD strongly preferred). + Your skills include a strong knowledge of relevant standards and regulations for the medical device industry (ISO, IEC, etc.). You have strong knowledge and understanding of Health Hazard Evaluations, Issue Impact Assessments, and Risk-Benefit Analyses and how to conduct them in a medical device environment. You have a Bachelor's/master's degree in medical, Nursing, or equivalent. MD preferred. + You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. + You're an excellent communicator, with an ability to influence cross-functional stakeholders utilizing your clinical expertise and knowledge of standard of care and medical device standards. **How we work together** We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is a field-based role. **About Philips** We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. + **Learn more about** **our business** **.** + **Discover** **our rich and exciting history.** + **Learn more about** **our purpose.** + **Learn more about** **our culture.** **Philips Transparency Details** The pay range for this position in AL, AZ, AR, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MI, MS, MO, MN, NC, ND, NE, NH, NM, NV, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WI, WV, or WY is $133,000 to $212,000. The pay range for this position in AK, DE, HI, MD, MN, and RI is $140,000 to $223,000. The pay range for this position in CA, CT, DC, MA, NJ, NY, or WA is $149,000 to $237,000. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. **Additional Information** US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits **will not** be provided for this position. \#LI-PH1 It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person's relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws. As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Equal Employment and Opportunity Employer/Disabled/Veteran

About the Company

Philips

At Philips, we don’t need employees. We need people.

Our goal is to improve the lives of 3 billion people a year by 2025 through innovation that is designed for people, by people. People like you. And we know that in order to be truly innovative, it requires you to make your career personally meaningful. To bring what matters to you in life to everything you do in your career. If you're passionate about improving lives, and have more to offer than just lines on your resume, we want to find a home for you at Philips.

As a diversified health and well-being company, we focus on professional and consumer markets across three interconnected sectors: Healthcare, Consumer Lifestyle, and Lighting. Today, we're a global innovation leader - the first to bring the commonly used CD and DVD products to market, the ones saving lives daily with our imaging systems and patient monitors, and the ones responsible for the lighting of the annual Times Square ball. We aim to improve peoples’ lives every day through meaningful innovations and are the best place to work for those who share our passion for improving lives.

Philips’ people first culture and commitment to providing unlimited possibilities to develop one's career in the directions to which they aspire demonstrates a dedication to inspiring good people, not just hiring employees. At Philips, employees enjoy contributing to cutting edge solutions that truly improve lives, allowing them to 'do good' while doing great and create a legacy in life through their work.

If you are interested in putting your personal skills & passions to work towards improving lives, apply now or learn more at philips.com/na/careers. You can also opt-in to receive updates on future career opportunities and company updates through Philips’ Talent Community, and follow @PhilipsJobsNA on Twitter.

COMPANY SIZE

10,000 employees or more

INDUSTRY

Other/Not Classified

FOUNDED

1933

WEBSITE

http://www.philips.com/na/careers

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