Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Job Title: Safety Operations Manager, Global Patient Safety (Japanese Speaking) Locations: Japan, Australia, New Zealand, Singapore, Taiwan, Thailand, India or Philippines. Position Summary: 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 This role reports into the Head of Global Patient Safety Operations or designee 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 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 within client and 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 client Controlled Procedures and with global and local regulations as applicable. Performs other tasks as assigned by line manager or Head of GPS Education and Experience: Bachelor’s /Master’s degree (or local equivalent) in nursing, healthcare or other life-science or relevant field Minimum of 5 years of relevant experience in Safety / Clinical Research / Pharmacovigilance At least 7 years of relevant experience in global pharmacovigilance/drug safety and practices (EU&US) and a strong focus on Japan PMDA regulations Proven experience in interactionwith 3rd party vendors Proven experience with the identification of quality issues and evaluation of quality metrics Knowledge, Skills, Abilities: Proficiency with safety database systems (i.e. Argus) and MedDRA coding 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 Japanese and English required
