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Cardinal Health

Medical Safety Manager

Cardinal Health - Mansfield, MA

Job Profile and Summary:This position will be responsible for management of all aspects of Medical Safety for medical devices globally; including safety investigations, complaint analysis, risk management documentation, review of published literature, escalation procedures and execution of processes for safety assessments and surveillance. The Medical Safety Manager will report to the Head of Medical Affairs and interact with Quality, Medical Affairs, Regulatory Affairs, Post-market Vigilance, and Risk Management departments in facilitating medical safety evaluations and decisions.He/she is accountable for implementing the Company’s standard operating procedures, standards of medical safety and care, available evidence and regulatory guidelines in daily decision-making.Essential duties and responsibilities:Lead and participate in cross-functional safety team meetings presenting and reviewing key patient safety product issues.Conduct medical evaluation of patient safety information from a variety of product data sources including clinical, post-market complaints, legal, and medical/scientific literature. Ensure safety issues are escalated appropriately to the Chief Medical Officer and Business Unit, per operating procedures.Ensure consistent and timely medical evaluation of complaints to determine reportable events.Partner with complaint handling, Medical Affairs, Post market vigilance, R&D, Risk Management and Regulatory groups to support appropriate reporting of adverse events to FDA, competent authorities and regulators.  Receive clinical input and determine reportability of product malfunctions, consequence codes, adverse events, probability & likelihood, and assist with the rationale in the Harms List.Provide medical safety input on new product development programs, risk management documentation, clinical study protocols, clinical safety plans, Clinical Evaluation Reports, clinical justifications for regulatory filings and post-market surveillance.    Coordinate complaints received through non-standard channels, such as verbal communications, clinical evaluations, literature and publications, etc.Act as a designee (of the Head of medical affairs) in medical safety processes.Performs medical assessment of Issue Impact Assessments, Health Hazard Evaluations/Health Hazard Analysis for potential field actions.Key role in compliance & ethics, maintains good relationships with internal and external compliance partners and ensures a professional clinical approach which is in compliance with highest ethical and scientific standards in which patient safety and data accuracy are prioritized.Participates in the development and maintenance of Medical Safety processes and SOPs.Shares accountability with others for a positive team spirit that is characterized by mutual support, understanding, encouragement, and an active exchange of new ideas.Essential qualifications:Technical skills:Clinical background or extensive clinical research experience in the device or pharmaceutical industry Experience in the medical safety role, knowledge of medical safety regulations, healthcare environment and compliance Ability to assess clinical results, summarize into reports and assist in authoring reports and justifications Ability to perform comprehensive medical literature searches and summarize results Project management skills Extensive knowledge of GCP, GLP, FDA and MEDDEV regulations Understanding of patient care and the clinical environmentCore 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 externallyEducation:Bachelor’s Degree in Nursing, Advanced degree preferredOther:Excellent written and oral English communication skillsKnowledge and proficient use of Microsoft Office Suite Applications and ability to navigate computer databases for complaint handling required.Posted TodayFull time20025775

8 days 11 hours ago

Cardinal Health


Medical Safety Manager Cardinal Health - Mansfield, MA, United States


Location: Mansfield, MA

Company Profile:
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a $103 billion health care services company that improves the cost-effectiveness of health care. As the business behind health care, Cardinal Health helps pharmacies, hospitals, ambulatory surgery centers, clinical laboratories and physician offices focus on patient care while reducing costs, enhancing efficiency and improving quality.