Case Specialist- Drug Safety
Posted Updated
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
Qualifications:
- 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.