Janssen Pqv Combo Products Analyst

Descripción del trabajo At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose : to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world. When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough. At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference : Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Job Responsibilities Perform high-volume end-to-end complaint handling activities, including intake, triage, review of the reported event, determination of MDR reportability, recovery of field samples for evaluation, and determination of Priority/Non-Priority. Conduct QP notification to LOC and perform due diligence with the complainant, intake centers, and LOC for trend analysis, defect coding, risk criticality assessment, ensuring accurate and holistic investigation, and review and closure. Evaluate complaints to determine if the QTLs or ULCs have been exceeded, assess the level of investigation required, and assign to the applicable site for investigation. Governance and oversight for daily throughput of complaints and MDR decisions to ensure prioritization and KPI are met. Perform MDR evaluations and document written justification to support reportable and non-reportable regulatory decisions. Monitor complaints for new malfunction events that may require inclusion in the malfunction description list (MDL). Serve as a PQV point person for post-market and complaint handling regulatory/MDR questions and inquiries; provide guidance and direction to subordinate Analyst roles and other PQV functions. Evaluate information from a technical perspective to ensure appropriate analysis and investigations/MDRs are accurately assessed for risk prioritization and performed per procedures, standards, and regulations. Back-up Product Quality Vigilance Investigation Support (PQVIS) personnel to support increased volume of complaints. Collaborate strongly with Global Medical Safety, manufacturing sites, and LOC/BQ for effective complaint handling/MDR assessments and adverse events with potential product quality issues. Use technical and product knowledge to provide accurate feedback for escalation/awareness of issues and for current product enhancements/future product development, if applicable. Ensure uniform and timely management of complaint records and regulatory reporting per procedures, standards, and regulations. Compile and analyze data, metrics, and trends associated with the complaint handling processes. Support internal and external audits and inspections; communicate regulatory and process positions as an SME during regulatory inspections. #J-*****-Ljbffr #J-18808-Ljbffr