Safety Operations Manager - Japanese Language

Position Overview

• Location Type: Japan (Timezone)
• Job Type: Full Time
• Salary: Not provided

Oversees operational delivery and staff within Global Patient Safety (GPS) Operations, in accordance with the GPS vision, strategy and regulatory requirements. Interacts with and provides guidance to internal functions and external vendors as required for seamless GPS Operations.

Responsibilities

• Oversees and coordinates with safety vendor and GPS teams regarding case triage and processing, expedited and aggregate reporting.
• Coordinates with and supports deliverables with GPS GSL team in relations to case case processing.
• Collaborates with other internal teams (including clinical, medical, or regulatory) and external parties (including HCPs, consumers, or contracted resources) regarding safety related deliverables and processes.
• Communicates with business partners or distributors regarding deliverables related to PV Agreements (PVA) / Safety Data Exchange Agreements (SDEA).
• Oversees assignment of Safety Specialist tasks, i.e. regarding timely monitoring of GPS communication.
• Proactively identifies issues and areas for improvement and escalates appropriately.
• Proactively engages in the development of new processes and procedures and leads implementation of those.
• Performs all activities in compliance with applicable Controlled Procedures and with global and local regulations as applicable.
• Performs other tasks as assigned by line manager or Head of GPS.

Skills and Competencies

• Advanced knowledge of medical terminology, pharmacovigilance processes and relevant regulations, including global requirements (e.g. EU, US, Japan).
• Proficiency with safety database systems (i.e. Argus) and MedDRA coding.
• Advanced computer skills, including proficiency with Microsoft Office including Excel, Power Point, Visio.
• Communicates complex issues in an understandable, effective and relevant manner.
• Manages and prioritizes a variety of tasks for self and team to meet required deadlines.
• Makes operational decisions with limited supervision and has a good understanding of the overall impact and potential risk.
• Identifies complex problems, raises issues and proposes solutions constructively.
• Proven ability to communicate effectively and collaborate successfully across functions and with vendors.
• Advanced communication in written and spoken English required.

Education, Experience, and Qualifications

• Bachelor’s / Master’s degree (or local equivalent) in nursing, healthcare or other life-science or relevant field.
• Must have JLPT N2 or above level certification.
• At least 7 years of relevant experience in global pharmacovigilance/drug safety (EU&US).
• Must have worked on PMDA PV related activities.
• Should have hands-on experience in managing resources who are working in PV case processing with Japanese Language Proficiency.
• Advanced expertise of global (EU/US) pharmacovigilance requirements and practices.
• Advanced experience with safety database systems (ARGUS preferred) including workflow management.
• Proven experience in interaction with 3rd party vendors.
• Proven experience with the identification of quality issues and evaluation of quality metrics.
• Willing to work in Japan Timezone.