Thermo Fisher Scientific is a global leader in serving science, enabling customers to make the world healthier, cleaner, and safer. With a mission to accelerate life sciences research, solve complex analytical challenges, and improve patient diagnostics, Thermo Fisher Scientific provides innovative solutions across pharmaceuticals, biotechnology, and healthcare.
Purpose of the Role
The Safety Operations Manager – Japanese Language will oversee operational delivery within Global Patient Safety (GPS) Operations, ensuring compliance with regulatory requirements and GPS strategy. This role involves coordinating with internal teams, external vendors, and business partners to manage pharmacovigilance (PV) activities efficiently.
Key Responsibilities
- Oversee safety vendor and GPS teams for case triage, processing, expedited, and aggregate reporting.
- Collaborate with GPS GSL team for case processing and regulatory compliance.
- Liaise with internal teams (clinical, medical, regulatory) and external partners (HCPs, consumers, vendors) on safety-related processes.
- Manage PV Agreements (PVA) / Safety Data Exchange Agreements (SDEA) with business partners.
- Assign and monitor Safety Specialist tasks, ensuring timely GPS communication.
- Identify process improvements, escalate issues, and lead implementation of new procedures.
- Ensure compliance with global PV regulations (EU, US, Japan) and internal procedures.
Skills & Competencies
- Advanced knowledge of medical terminology, pharmacovigilance, and global PV regulations (EU, US, Japan).
- Proficiency in safety databases (Argus preferred) and MedDRA coding.
- Strong Microsoft Office (Excel, PowerPoint, Visio) skills.
- Excellent communication (written & spoken English + Japanese – JLPT N2 or above).
- Ability to prioritize tasks, solve complex problems, and make operational decisions.
- Experience in vendor management and quality metrics evaluation.
Education & Experience
- Bachelor’s/Master’s in nursing, healthcare, life sciences, or related field.
- JLPT N2 or higher certification (mandatory).
- 7+ years in global pharmacovigilance/drug safety (EU & US).
- Hands-on experience with PMDA PV activities.
- Experience managing Japanese-speaking PV case processing teams.
- Willingness to work in Japan Timezone (JST).