[Innovative Medicine] Manager, Case Management, Local Medical Safety, Japan

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 jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Product Safety Job Sub Function: Pharmacovigilance Job Category: People Leader All Job Posting Locations: Chiyoda, Tokyo, Japan Job Description: JOB SUMMARY: ■         Leads operational management of a Case Management Group consisting of individual contributors, implements operational plans with adequate business purpose, and is accountable for ensuring efficient, compliant, high-quality, timely case management operations while optimizing resource utilization and operational throughput. ■         Communicates and builds effective relationships with relevant stakeholders outside LMS Japan, including global and regional stakeholders as appropriate, to provide vision, strategic direction and/or alignments in the case management and stakeholders.

1. Ensure the quality of outputs related to case processing activities and maintain compliance with applicable timelines. Control the quality of outputs provided to PMDA, Global Medical Safety (GMS), Local Medical Safety (LMS), and other groups for safety-related activities, including but not limited to aggregate reports, risk management plans, and safety information distribution to healthcare professionals (HCPs). Lead kinds of implementation plan in case management and improvement with the risk-based approach. Control compliance with timelines for PMDA reporting and headquarters reporting in the case management group. Escalate compliance risks with potential countermeasures to supervisors and stakeholders. Monitor the quality and compliance of the adverse event (AE) reporting process. Plan and take appropriate countermeasures with alignment in stakeholders as needed. Establish more efficient and reliable case processing in accordance with business requirements, including the utilization of outsourcing where appropriate. Evaluate the impact of new SOPs and related regulations, and implement new or revised processes with alignment in stakeholders as needed. Handle internal audits and external inspections related to case processing such as investigation (root cause analysis), proposing corrective/preventive action, alignment with stakeholders and escalation to supervisor (if required), with proactive manner. Build and maintain effective communication with LMS Japan personnel and other relevant stakeholders, including GMS, LMS, other functions, and sectors, to ensure reliable case processing. Specifically, provide advice and align with stakeholders as SME. Escalate to supervisor (if necessary). Perform other related duties as required. 2. Operational management in the Case Management Group and staff Identify resource demands and visualize appropriate resources allocation for ICSR operation within the group. Propose appropriate assignment of case processing tasks to staff and monitor the status and progress of those tasks. Provide appropriate On-the-Job (technical) training and guidance to staff, and coach and train junior colleagues. Escalate operational risks to supervisor, if necessary.

Experience Previous industry and/or clinical experience with a focus on pharmaceutical safety-related areas,