Safety Operations Manager - EMEA- FSP

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Position Summary

As the Safety Operations Manager - EMEA- FSP, you will play a meaningful role in ensuring outstanding operational delivery within our Global Patient Safety (GPS) Operations. You will interact and collaborate with internal teams and external vendors to strictly adhere to our GPS vision, strategy, and regulatory requirements. Reporting to the Head of Global Patient Safety Operations, you will lead various safety-related deliverables and processes with flawless execution.

Responsibilities

• Lead all aspects of and coordinate with safety vendors and GPS teams regarding case triage and processing.
• Ensure timely delivery of expedited and aggregate reporting.
• Collaborate with internal teams and external parties on safety-related deliverables.
• Communicate with clients and business partners regarding PV Agreements (PVA) and Safety Data Exchange Agreements (SDEA).
• Proactively identify issues and areas for improvement, advancing as needed.
• Engage in the development and successful implementation of new processes and procedures.
• Perform all activities in compliance with applicable client Controlled Procedures and global/local regulations.

Education and Experience

• Bachelor’s/Master’s degree in nursing, healthcare, or a relevant field.
• Minimum of 5 years of experience in Safety, Clinical Research, or Pharmacovigilance.
• At least 7 years of experience in global pharmacovigilance/drug safety, with a focus on Japan PMDA regulations.
• Proven experience in interacting with third-party vendors and identifying quality issues.

Knowledge, Skills, Abilities

• Proficiency with safety database systems (e.g., Argus) and MedDRA coding.
• Ability to communicate complex issues in an understandable and effective manner.
• Skill in managing and prioritizing tasks to meet deadlines.
• Capability to make operational decisions with a good understanding of impact and risk.
• Advanced communication skills in written and spoken Japanese and English.

Benefits

We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific provides an innovative, forward-thinking environment with outstanding career and development prospects. We stand for integrity, intensity, involvement, and innovation!