Join to apply for the Safety Operations Manager - EMEA- FSP role at Thermo Fisher Scientific .
Work Schedule : Standard (Mon-Fri)
Environmental Conditions : Office
Position Summary
As the Safety Operations Manager - EMEA- FSP, you will play a key role in ensuring operational excellence within our Global Patient Safety (GPS) Operations. You will collaborate with internal teams and external vendors to adhere to our GPS vision, strategy, and regulatory requirements. Reporting to the Head of Global Patient Safety Operations, you will lead safety-related deliverables and processes with high precision.
Responsibilities
* Lead safety vendors and GPS teams in case triage and processing.
* Ensure timely delivery of expedited and aggregate safety reports.
* Coordinate with internal and external stakeholders on safety deliverables.
* Communicate with clients and partners regarding PV Agreements (PVA) and Safety Data Exchange Agreements (SDEA).
* Identify issues proactively and implement improvements.
* Develop and implement new safety processes and procedures.
* Ensure compliance with client-controlled procedures and global / local regulations.
Education and Experience
* Bachelor’s or Master’s degree in nursing, healthcare, or a related field.
* At least 5 years of experience in Safety, Clinical Research, or Pharmacovigilance.
* Minimum of 7 years in global pharmacovigilance / drug safety, focusing on Japan PMDA regulations.
* Experience working with third-party vendors and quality assurance.
Knowledge, Skills, and Abilities
* Proficiency with safety database systems (e.g., Argus) and MedDRA coding.
* Excellent communication skills in Japanese and English.
* Strong task management and prioritization skills.
* Operational decision-making with awareness of impact and risk.
We offer competitive pay, annual bonuses, healthcare, and other benefits. Join an innovative environment with growth opportunities. We value integrity, involvement, and innovation.
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