Manager Global Post Market Safety
Johnson & Johnson is currently recruiting for a Manager Global Post Market Safety! This position will be located in Irvine, CA.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Position Summary:
Manages global complaint handling and adverse event reporting activities related to medical or other devices manufactured and/or distributed. Manages evaluation of incoming product complaints, reportability assessment decisions per Health Canada Drug and Medical Device regulations including global regulations. Adheres to environmental policy, procedures, and supports department environmental objectives.
Key Responsibilities:
Develops improvements to existing complaint processing system. Creates systems for compiling metrics and trending of customer complaints and adverse events. Interfaces with local government regulatory, quality control systems and external auditing bodies. Mentors and facilitates successful team behavior in the development of the customer complaint department. Manages staff to resolve complaints for all products and ensures all regulatory requirements are maintained. Ensures that incoming complaints are reviewed for reportability and that follow up is provided to external customer as required. Provides direction and leadership for the investigation and resolution of all customer complaints in a timely manner.
Main areas of responsibility:
Manages and coordinates activities of employees engaged in the complaint handling and adverse event reporting process. In addition, may be required at times to complete these tasks. May manage both Non Exempt and Exempt associates including Healthcare Professionals.
In addition to managing complaint handling, provide Quality Assurance leadership with product quality data, statistical analysis and complaint trending to drive product improvements and Corrective and Preventive Actions. In conjunction with Corporate QA, assists in field actions (including product recalls) as required.
Prepare or assist department leadership with monthly trending reports, annual post-market surveillance reports and other monthly and quarterly reports. Lead or participate in various process improvement projects.
Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising and managing performance; addressing complaints and resolving problems.
Evaluate complaints and investigation conclusions for medical impact with review and consideration of product risk management information. Establish medical impact classifications for product complaints and support alignment with the product risk management process.
