Medical Safety Manager - EI

Philips

11d•$133,000 - $237,000•Remote

About The Position

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.

Requirements

7+ years of experience in areas such as Medical/Clinical affairs in Medical Device/Biotech industry or equivalent.
Active clinical license (Nursing or MD strongly preferred).
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. MD preferred.
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
Excellent communicator, with an ability to influence cross-functional stakeholders utilizing your 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.

Responsibilities

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.