Medical Safety Manager, Hospital Patient Monitoring

Job Description:

• Conducting comprehensive evaluations of safety information sourced from a variety of channels such as Post-Marketing Surveillance (PMS) and literature searches
• 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
• 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)
• Conducts literature reviews and surveillance activities to identify emerging safety issues
• Provides answers to safety-related inquiries from healthcare professionals, patients, and internal stakeholders
• Contributes to the implementation of safety-related policies, procedures, and programs to promote a culture of safety and compliance within the organization

Requirements:

• 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 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 minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position
• Willing and able 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

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