Cardinal Health Safety Specialist - Remote Nursing Opportunity in Rhode Island, Rhode Island

What Clinical Specialty contributes to Cardinal Health

Clinical Specialty is responsible for providing quality, timely, granular and actionable data for selected operational and clinical metrics, as well as tracking and identifying trends for healthcare data and providing benchmark comparisons for healthcare providers.

This position will be responsible for performing safety investigations, complaint analysis, risk management documentation, review of published literature, escalation procedures and execution of processes for safety assessments and surveillance for the global Medical Safety Program for medical devices. The Safety Specialist will report to the Manager of Medical Safety. The Safety Specialist will work collaboratively with key team members, Quality, Medical Affairs, Regulatory Affairs, Post-market Vigilance, and Risk Management departments in facilitating medical safety evaluations and decisions.

He/she is accountable for utilizing the Company’s standard operating procedures, medical safety standards, evidenced-based medicine and/or standard of care, and regulatory guidelines in daily decision-making.

Essential duties and responsibilities:

Conduct medical evaluation of global patient safety occurrence from a variety of product data sources including clinical, post-market complaints, legal, regulatory and medical/scientific literature. Perform post market complaints investigations to ensure timely completion of Safety Medical Assessments and submission of reportable events. Escalate safety issues appropriately to Medical Safety Manager and Business Unit per operating procedures. Perform safety assessment for Distributed Product Risk Assessment (DPRA), Health Hazard Evaluations/Health Hazard Analysis to support timely identification of potential field actions and completion of DPRA. Collaborate and serve as clinical consultant with Post Market Vigilance Analyst, R&D, Quality, Risk Management and Regulatory groups to support appropriate reporting of adverse events to FDA, and other global competent authorities and regulators. Participate in the development and maintenance of Medical Safety processes and Standard Operating Procedures. Provide clinical expertise and knowledge for new products, clinical trials, Change Development Process, Clinical Evaluation Reports, Master Harms List, and Risk Management Remediation for Medial Affairs. Manage complaints received through non-standard channels in a timely manner, such as verbal communications, clinical evaluations, literature and publications, etc. Identify safety triggers and unexpected serious harm events to determine severity of harm and appropriate escalation per operating procedures. Serve as clinical consultant for new and updates to product Information of Use to ensure appropriate safety standards, risk and precautions are included. Initiate and implement updates to Risk Management file for newly identified harm or change in level of severity based on information from recent complaint investigations. Perform weekly coding review and attend weekly meeting for all new complaints to ensure correct coding, initiation of escalations and safety medical assessments.

Essential qualifications:

Technical skills:

Clinical background and understanding of patient care across the care continuum. Experience in quality and patient safety or clinical risk management, knowledge of medical compliance standards and regulations. Ability to assess clinical outcomes, perform data analysis and summarize into reports. Ability to perform comprehensive medical literature searches and summarize results Project management skills.

What is expected of you and others at this level

Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects

  • Participates in the development of policies and procedures to achieve specific goals
  • Recommends new practices, processes, metrics, or models
  • Works on or may lead complex projects of large scope
  • Projects may have significant and long-term impact
  • Provides solutions which may set precedent
  • Independently determines method for completion of new projects
  • Receives guidance on overall project objectives
  • Acts as a mentor to less experienced colleagues

Core skills:

Strong work ethic, patient focus and commitment to serve internal and external clients Proactive with a sense of urgency in managing job responsibilities Energy, focus, motivation and debate-friendly Analytical thinking and inquisitive mindset for investigations and problem solving Team player, “ can-do ” attitude and excellent interpersonal skills Ability and desire to develop good working relationships internally and externally Practice and share accountability with others for a positive team spirit characterized by mutual support of corporate culture, understanding, encouragement, and an active exchange of new ideas.

Qualifications

  • Undergrad required
  • Active nursing license
  • Advanced degree preferred
  • 6 - 8 years of experience in related field

Education:

  • Bachelor’s Degree in Nursing, Advanced degree preferred

Other:

  • Excellent written and oral English communication skills
  • Knowledge and proficient use of Microsoft Office Suite Applications and ability to navigate computer databases for complaint harm investigation is required.

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.