Thermo Fisher Scientific

Safety Operations Manager - Japanese Language

India

Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries

Requirements

Candidates must possess a Bachelor’s or Master’s degree in nursing, healthcare, or a related life-science field, and a minimum of seven years of experience in global pharmacovigilance/drug safety, specifically with EU and US requirements. They are required to hold a JLPT N2 or above level certification in Japanese, demonstrating advanced proficiency in the language. Advanced knowledge of medical terminology, pharmacovigilance processes, and relevant regulations, including global requirements (e.g., EU, US, Japan), is essential, along with proficiency in safety database systems such as Argus and MedDRA coding.

Responsibilities

The Safety Operations Manager will oversee operational delivery and staff within Global Patient Safety (GPS) Operations, providing guidance to internal functions and external vendors. They will coordinate with safety vendors and GPS teams regarding case triage and processing, support the GPS GSL team with case processing, collaborate with internal and external parties on safety-related deliverables, and communicate with business partners regarding PV Agreements (PVA) / Safety Data Exchange Agreements (SDEA). The role involves overseeing the assignment of Safety Specialist tasks, proactively identifying issues and areas for improvement, developing new processes and procedures, and implementing them. Furthermore, the manager will perform activities in compliance with regulations, and perform other tasks as assigned by the line manager or Head of GPS.

Skills

Medical Terminology
Pharmacovigilance
Argus
MedDRA
Microsoft Office
Excel
PowerPoint
Visio
Communication
Prioritization

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Key Metrics

Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.
Sale of anatomical pathology business could create a temporary product gap.
Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.
Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.
They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.
Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.
Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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