[Hiring] Medical Safety Manager @Philips

Role Description

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.

• 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.

Qualifications

• 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.
• Strong knowledge and understanding of Health Hazard Evaluations, Issue Impact Assessments, and Risk-Benefit Analyses.
• Bachelor’s/master’s degree in medical, Nursing, or equivalent; MD preferred.

Requirements

• Ability to successfully perform the minimum Physical, Cognitive and Environmental job requirements with or without accommodation.
• Excellent communication skills with the ability to influence cross-functional stakeholders utilizing clinical expertise and knowledge of standard of care and medical device standards.
• Willingness and ability to travel up to 25% based on business needs.

Benefits

• Generous PTO.
• 401k (up to 7% match).
• HSA (with company contribution).
• Stock purchase plan.
• Education reimbursement.
• Comprehensive Philips Total Rewards benefits program.