Medical Safety Manager, Hospital Patient Monitoring

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.

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.

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