Janssen- Post Market Analyst 4

• Represents the Post Marketing Risk Management department on multi-disciplinary teams • Responsible for activities related to product safety surveillance and risk management including review of data from clinical studies, literature articles and spontaneous complaints for accuracy, completeness, regulatory reporting and potential safety issues.• Provide guidance to complaint handling specialist, customers, sales reps and clinical studies/registries in order to assess product… Show more • Represents the Post Marketing Risk Management department on multi-disciplinary teams • Responsible for activities related to product safety surveillance and risk management including review of data from clinical studies, literature articles and spontaneous complaints for accuracy, completeness, regulatory reporting and potential safety issues.• Provide guidance to complaint handling specialist, customers, sales reps and clinical studies/registries in order to assess product relationship to reported complaint.• Monitor surveillance data to identify any triggers and safety concerns• Monitor/Assess customer complaints for potential regulatory reporting, and product quality trends.• Verify assessments of regulatory reporting requirements for accuracy • Review complaints to determine reportability to appropriate regulatory health authorities and assist the complaint specialist in Customer Quality with direction on how to accurately capture, document and process complaints. • Compose clinical conclusions to be included global regulatory reports • Ensure safety surveillance operational activities supporting product release are efficient, effective and meet target deadlines from both a compliance and business perspective.• Coordinate, prepare, and review of complaint data for regulatory submissions for domestic or international projects• Provide mentoring/coaching/training to employees • Participate in internal/external audits.• Assist with developing and launching training for Customer Quality regarding the use of encryption and “Secure!” to protect patient health information (PHI Initiative). Show less

• Responsible for assisting the Customer Technical Support Manager in overseeing the accuracy and completeness of providing Post Market Customer Technical Support to customers by delivering a superior customer experience. • Assisted the team in appropriately managing and assessing customer needs for technical support and document in accordance with good documentation practices and applicable regulations.• Supported tracking, trending, and auditing of post market data in order to ensure… Show more • Responsible for assisting the Customer Technical Support Manager in overseeing the accuracy and completeness of providing Post Market Customer Technical Support to customers by delivering a superior customer experience. • Assisted the team in appropriately managing and assessing customer needs for technical support and document in accordance with good documentation practices and applicable regulations.• Supported tracking, trending, and auditing of post market data in order to ensure that post market information is available to support continuous product improvement and to ensure that customer post market needs are met.• Managed the day to day operations to ensure that the Customer Technical Support queues are managed by doing the following: reviewing staffing to ensure queue coverage, representing the department at interdepartmental projects and initiatives, following up as needed with customer concerns or questions, helping to oversee the quality monitoring process, and providing technical and problem solving support to staff to ensure that customer service expectations are maintained. • Performed training and also identify and communicate educational training needs of staff, ensure that initial assessment of any potential health and safety issues are completed and clearly documented as part of the call capture, as well as support return goods reconciliation process and due diligence to facilitate complaint investigation and/or in accordance to the Warrantee policy and relevant procedures.• Supported the launch of new products by ensuring product training is kept up to date.• Acted as a liaison with other departments to represent department, and perform other work-related duties as assigned.• Acted as a subject matter expert (SME) in complaint capture and identifying and documenting adverse events related to insulin pumps and supplies.• Coordinated training program for new hire onboarding for customer technical representatives Show less