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About the Role

This role involves managing safety information for clinical trials and post-marketing surveillance of pharmaceuticals and medical devices. You will be hands-on with a wide range of tasks including receiving safety information, database entry, and quality control.

Responsibilities

• Receive, triage, assign numbers to, enter into the database, perform primary evaluation for PMDA reporting necessity, and QC safety information.
• Create and QC narrative descriptions of case progression (Japanese/English) and reports for the PMDA.
• Create queries for information necessary for safety evaluation.
• Detect individual cases, study reports, and adverse event reports from domestic and international literature and overseas measures information.
• Enter and QC data based on the evaluation of domestic and international literature and overseas measures information, and create and QC reports for the PMDA.
• Report to the PMDA, client partner companies, and clinical trial sites using various reports.
• Aggregate cases and detect/evaluate signals.
• Create, QC, and report to authorities on draft periodic safety update reports, draft periodic reports on infectious diseases, draft periodic reports on unknown non-serious adverse events, and draft annual reports on clinical trials.
• Create and QC line listings for clinical trial sites.

Requirements

• Minimum of 3 years of experience in any aspect of safety information case processing (receipt, triage, numbering, content confirmation, database entry/QC). (Consultation is possible for those with limited experience, such as receipt or numbering).
• Business-level Japanese proficiency.
• Education beyond high school, junior college, or vocational school.
• Ability to build good relationships with other departments and team members.

Skills

• Safety information case processing
• Database entry
• Quality control
• Report creation
• Literature review
• Translation (Japanese to English)
• English proficiency (TOEIC 600 or equivalent)

Location

• Remote (Flexible Style Work)
• On-site at Shinagawa Headquarters (Tokyo)
• On-site at Shin-Osaka Office (Osaka)

Work Type

• Remote
• Hybrid

Experience Level

• 3+ years in safety information case processing

Education Level

• Post-secondary education (High school, Junior College, Vocational School, or higher)
• Medical-related academic background (Medicine, Pharmacy, Clinical Laboratory Science, Nursing, etc.) - Preferred

About the Company

• IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.
• IQVIA operates in over 100 countries and is a leader in the CRO industry.
• Recognized by Fortune as one of the 'World's Most Admired Companies' in 2025, ranking first in the Healthcare (Pharmacies & Other Services) category for the fourth consecutive year.
• IQVIA Services Japan is the largest pharmaceutical contract research organization in Japan, leading the industry in the development of not only the latest global pharmaceutical studies but also medical devices and regenerative medicine.
• We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
• We seek diverse talent with curious minds and a relentless commitment to innovation and impact.
• Everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Equal Opportunity

• IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.