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Medical Safety Manager, Hospital Patient Monitoring

Role overview

Qualifications

  • 5+ years of experience with Bachelor’s or 3+ years of experience with Master’s in Medical/Clinical affairs in Medical Device/Biotech industry
  • Critical Care and/or Telemetry experience required
  • Experience as a practicing clinician is required
  • Bachelor’s/master’s degree in medical, Nursing, or equivalent; MD preferred

Responsibilities

  • Conduct comprehensive evaluations of safety information from various channels such as Post-Marketing Surveillance and literature searches
  • Provide support for patient safety insights in processes like Risk Management and Risk-Benefit analyses
  • Collaborate on safety inputs for regulatory submissions and clinical documents to ensure compliance
  • Analyze safety data from clinical trials and post-market surveillance to identify potential safety signals

Key facts

  • Remote from: United States
  • Full time
  • Senior (5-10 years)
  • Medical Administrator
  • English

Hard skills

Other skills

  • Communication
  • Collaboration

About the company

Philips  logo

Philips

Digital Health & Health Tech

Over the past decade we have transformed into a focused leader in health technology. At Philips, our purpose is to improve people’s health and well-being through meaningful innovation. We aim to improve 2.5 billion lives per year by 2030, including 400 million in underserved communities. We see healthcare as a connected whole. Helping people to live healthily and prevent disease. Giving clinicians the tools they need to make a precision diagnosis and deliver personalized treatment. Aiding the patient's recovery at home in the community. All supported by a seamless flow of data. As a technology company, we – and our brand licensees – innovate for people with one consistent belief: there’s always a way to make life better. Visit our website: http://www.philips.com/ Follow our social media house rules https://www.philips.com/a-w/about-philips/social-media.html

Company details

Company typeXLarge
IndustryDigital Health & Health Tech
Company size10001

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Job description

Job Title

Medical Safety Manager, Hospital Patient Monitoring

Job Description

Medical Safety Manager, HPM

The Medical Safety Manager, Hospital Patient Monitoring 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 improving patient safety.

You're the right fit if:

  • You’ve acquired 5+ years of experience with Bachelor’s OR minimum 3+ years of experience with Master’s in areas such as Medical/Clinical affairs in Medical Device/Biotech industry or equivalent. Critical Care, and/or Telemetry experience required. Experience as a practicing clinician is required.
  • 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/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. You must be willing and able to travel up to 25% based on business needs.

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. EDT and CDT time zone preferred.

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.

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

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 including Disability/Vets and maintains a drug-free workplace.

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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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