Medical Safety Manager, Hospital Patient Monitoring

Philips•Cambridge, MA

1d•Remote

About The Position

The Medical Safety Manager, Hospital Patient Monitoring is responsible for conducting comprehensive evaluations of safety information sourced from a variety of channels such as Post-Marketing Surveillance (PMS) and literature searches, working under limited supervision. This 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. It 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. The role 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. It conducts literature reviews and surveillance activities to identify emerging safety issues, ensuring proactive identification and mitigation of potential risks. The role provides answers to safety-related inquiries from healthcare professionals, patients, and internal stakeholders, fostering trust and transparency in communication regarding product safety. It contributes to the implementation of safety-related policies, procedures, and programs to promote a culture of safety and compliance within the organization. The role maintains awareness of evolving regulations and guidelines related to medical product safety and ensures compliance with applicable requirements. It provides input into the design and conduct of safety studies and medical device vigilance activities to ensure robust safety surveillance throughout the product lifecycle. Finally, it 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.

Requirements

5+ years of experience with a Bachelor's degree OR minimum 3+ years of experience with a Master's degree in Medical/Clinical affairs in the Medical Device/Biotech industry or equivalent.
Critical Care, and/or Telemetry experience required.
Experience as a practicing clinician is required.
Strong knowledge of relevant standards and regulations for the medical device industry (ISO, IEC, etc.).
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.
Bachelor’s/master’s degree in medical, Nursing, or equivalent.
Excellent communication skills, with an ability to influence cross-functional stakeholders utilizing clinical expertise and knowledge of standard of care and medical device standards.
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.

Nice To Haves

MD preferred.

Responsibilities

Conduct comprehensive evaluations of safety information from Post-Marketing Surveillance (PMS) and literature searches.
Provide insights and recommendations for Risk Management, Health Hazard Evaluations (HHE), Risk-Benefit analyses, and recall procedures.
Offer safety-related perspectives for New Product Introduction (NPI) projects, clinical studies, and Post-Marketing Surveillance (PMS).
Furnish safety inputs for regulatory submissions and documents like Risk-Benefit Analyses (RBA), protocols, Clinical Study Reports (CSR), and Clinical Evaluation Reports (CERs).
Conduct literature reviews and surveillance to identify emerging safety issues.
Respond to safety-related inquiries from healthcare professionals, patients, and internal stakeholders.
Contribute to the implementation of safety-related policies, procedures, and programs.
Maintain awareness of evolving regulations and guidelines related to medical product safety.
Provide input into the design and conduct of safety studies and medical device vigilance activities.
Analyze safety data from clinical trials and post-market surveillance to identify potential safety signals and trends.