Medical Safety Manager
United States of America - Remote Based
Job Title
Medical Safety ManagerJob Description
Medical Safety Manager
The Medical Safety Manager is 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 proactive 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 improves patient safety.
You're the right fit if:
- You’ve acquired 5+ years of experience with a bachelor’s degree or 3+ years experience with a master’s degree in areas such as Medical/Clinical Affairs/Medical Safety in the Medical Device industry.
- Your skills include a strong 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 degree or higher in Medical Science, Nursing or equivalent. Master’s degree or higher 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 commitment to diversity and inclusion.
Philips Transparency Details
The pay range for this position in AZ, AR, ID, IA, KS, KY, LA, ME, MS, MO, MT, NE, NM, OK, SC, SD, TN, UT, and WV are $122,906 to $196,650.
The pay range for this position in AL, CO, FL, GA, IL, IN, MI, MN, NV, NH, NC, ND, OH, OR, PA, TX, VT, VA, WI, and WY are $129,375 to $207,000.
The pay range for this position in AK, DE, HI, MD, RI, and WA is $135,844 to $217,350.
The pay range for this position in CA, CT, MA, NJ, NY, DC, is $144,900 to $231,840.
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.
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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
ApplyJob Profile
RestrictionsField-based role Onsite roles require full-time presence Onsite roles require in-person presence US work authorization
Benefits/Perks401k up to 7% match Annual Incentive Bonus Collaborative environment Commitment to diversity Diversity and Inclusion Education reimbursement Generous PTO Healthcare access Health technology company HSA HSA with company contribution Long-term incentives PTO Remote work Sales commission Stock Purchase Plan
Tasks- Analyze safety data
- Conduct literature reviews
- Evaluate safety information
- Provide safety-related insights
- Support patient safety initiatives
Clinical Clinical evaluation Clinical expertise Clinical Studies Clinical trials Communication Compliance Cross-functional Collaboration CT Education Environmental Healthcare Health hazard evaluations IEC standards Implementation ISO Standards Literature reviews Marketing Medical device Medical device industry Medical safety Nursing Office OR Organization Post-marketing surveillance Risk-benefit analyses Risk Management Safety data analysis Sales Teams Technology
Experience5 years
EducationBachelor Bachelor's degree Business Clinical Degree DO Equivalent IT MA Marketing Master Master's degree Medical Medical science MS Nursing Sales Science