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

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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. KEY RESPONSIBILITIES: 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. Requirements: Experience Previous industry and/or clinical experience with a focus on pharmaceutical safety-related areas, including individual case processing and aggregate reporting preferred. Typically demonstrated by a minimum of 6 years of pharmaceutical industry experience. Experience working in a cross-cultural and/or global environment is required. Extensive knowledge of and experience with safety reporting and regulatory compliance, including experience with international safety reporting requirements and regulations. Knowledge & Skills Sound knowledge of general medicine, pharmacy, or clinical practice, with proficiency in medical terminology (local language). Strong leadership skills and the ability to lead a team. Ability to negotiate and communicate effectively with internal and external customers. Ability to plan allocation of case assessment resources. Ability to evaluate processes and procedures against outcomes and identify opportunities to improve efficiency, accuracy, and compliance. Ability to prioritize work and operate effectively under strict timelines on a daily basis. Demonstrates strong Credo values. Strong English communication skills (TOEIC 800 or above preferred), including verbal, written, presentation, and facilitation skills. Good computer skills (Word, Email, Excel, PowerPoint) and familiarity with safety systems. Qualifications / Certifications Bachelor's degree or equivalent education in Health Sciences or another directly related field, or an equivalent combination of education, training, and experience. Reporting Relationships Reports To: Associate Director of Case Management ＜For Internal Applicants＞ Based on your experience and interview evaluation, the position title and level may vary. If you are Japan employee, please read “Internal Application Guideline” in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan’s employee, you are not able to apply for multiple positions at once. For Employee Referral Program (ERP), please read and understand the details of the “Internal Referral Overview” on the Ask GS and you have made a compliant referral. Required Skills: Preferred Skills: Cross-Functional Collaboration, Developing Others, Global Market, Inclusive Leadership, Leadership, Medicines and Device Development and Regulation, Operations Management, Performance Measurement, Pharmacovigilance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Affairs Management, Report Writing, Safety Investigations, Safety-Oriented, Safety Reporting, Serious Adverse Event Reporting, Team Management