Job description
Key Responsibilities
Perform end-to-end individual case safety report (ICSR) processing, including data entry, narrative writing, coding, and follow-up activities. Ensure compliance with local and global regulatory requirements, internal SOPs, and timelines. Support the Safety Manager in Japan with case review, quality control, and timely submission to health authorities.
Collaborate with the Regional Safety Head and global PV team to align on case handling procedures and updates. Assist in the preparation of safety reports, such as PBRERs, DSURs, and ad hoc safety summaries. Participate in audits, inspections, and training activities as needed.
Requirements
Minimum of 2–4 years of pharmacovigilance case processing experience, preferably in a global environment. Familiarity with Japanese and global PV regulations (PMDA, ICH, etc.). Strong written and verbal communication skills in Japanese and English. Excellent attention to detail and ability to work under deadlines.