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.

Work and collaborate with clients based in Japan

Interacts with and provides guidance to internal functions and external vendors as needed for seamless GPS Operations

REPORTING LINE

Head of Global Patient Safety Operations or designee

ROLES AND 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 brings up 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

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

Handles 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

Ability to communicate effectively and collaborate successfully across functions and with vendors

Advanced communication in written and spoken Japanese is required

EDUCATION, EXPERIENCE AND QUALIFICATIONS

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 (EU&US)

Equivalent and adequate combination of education and experience

Advanced expertise of global (EU/US) pharmacovigilance requirements and practices

Advanced experience with safety database systems (ARGUS preferred) including workflow management

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!