Client is working with a global contract research organisation operating at the forefront of pharmaceutical development and safety services. The business combines international reach with a strong local presence in Japan, supporting clinical research, pharmacovigilance, regulatory activities, and related specialist services for life sciences clients.
The organisation is part of a wider global network and offers an environment where professionals can work on international projects, collaborate across regions, and build expertise in highly regulated healthcare operations. It is an attractive place to work for those who value precision, teamwork, and the opportunity to contribute to the safe development and monitoring of medicines.
As a Safety Specialist, you will support pharmacovigilance activities for global clinical trials and marketed products. The role focuses on the handling of safety information across the full process, from triage and data entry through to quality control and the preparation of draft regulatory reports.
You will also support the provision of safety information to investigational sites, including line list preparation, and carry out translation work as required. In addition, you will assist project team members to ensure that safety case processing and related PV tasks are completed accurately, proactively, and in line with established procedures. This is a temporary assignment within the PV function, based in either Tokyo or Osaka.
3+ years of pharmacovigilance experience, or strong hands-on expertise in data entry and quality control within PV case processing
Solid understanding of the end-to-end safety information workflow for investigational and marketed products, including receipt, triage, entry, QC, and reporting to PMDA
Practical ICSR handling experience, including input, assessment, translation, QC, and transmission
Experience working in English in a professional setting
Basic working knowledge of Word, Excel, and Outlook
Ability to work independently and proactively in a regulated environment
Temporary assignment with the possibility of renewal
No relocation required
Opportunity to work in either Tokyo or Osaka
Exposure to global pharmacovigilance activities and international stakeholders
