Work Schedule

Environmental Conditions

Job Description

PURPOSE OF THE FUNCTION

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

ROLES AND RESPONSIBILITIES

Oversees and coordinates with safety vendor and GPS teams regarding case triage and processing, expedited and aggregate reportingCoordinates with and supports deliverables with GPS GSL team in relations to case processingCollaborates with other internal teams (including clinical, medical, or regulatory) and external parties (including HCPs, consumers, or contracted resources) regarding safety related deliverables and processesCommunicates 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 communicationProactively identifies issues and areas for improvement and escalates appropriatelyProactively engages in the development of new processes and procedures and leads implementation of thosePerforms 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 codingAdvanced computer skills, including proficiency with Microsoft Office including Excel, Power Point, VisioCommunicates complex issues in an understandable, effective and relevant mannerManages and prioritizes a variety of tasks for self and team to meet required deadlinesMakes operational decisions with limited supervision and has a good understanding of the overall impact and potential riskIdentifies complex problems, raises issues and proposes solutions constructivelyProven ability to communicate effectively and collaborate successfully across functions and with vendorsAdvanced 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 fieldMust have JLPT N2 or above level certificationAt least 7 years of relevant experience in global pharmacovigilance/drug safety (EU&US)Must have worked on PMDA PV related activitiesShould have hands on experience in managing resource who are working in PV case processing with Japanese Language ProficiencyAdvanced expertise of global (EU/US) pharmacovigilance requirements and practicesAdvanced experience with safety database systems (ARGUS preferred) including workflow managementProven experience in interaction with 3rd party vendorsProven experience with the identification of quality issues and evaluation of quality metricsWilling to work in Japan Timezone