The Assistant II PSS plays a key role in supporting pharmacovigilance and clinical safety functions by accurately processing and tracking safety information from clinical trials and post-marketing sources. You will be responsible for handling expedited and periodic safety reports, ensuring timely documentation and distribution in alignment with project timelines and regulatory expectations.
What You'll Do
You will assist in entering and managing adverse event data in safety tracking systems, ensuring all reports are logged and forwarded appropriately. This includes preparing patient narratives, coding events using MedDRA, and supporting listedness assessments when applicable. You will generate queries to resolve data discrepancies in collaboration with medical staff and help ensure all submissions to clients and regulatory bodies are completed on schedule.
Additional responsibilities include maintaining project and central safety files, supporting database reconciliations, and assisting with quality reviews of processed reports. You will contribute to meeting regulatory compliance standards by adhering to SOPs and work instructions within the Quality Management System. Administrative duties such as scheduling meetings and supporting team coordination are also part of the role.
Requirements
A Bachelor’s, Master’s, or PharmD degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, or a related field is required. Up to one year of relevant experience in safety reporting, clinical data management, or a related pharmaceutical function is preferred. Experience with adverse event databases, regulatory submissions, and narrative writing is essential.
Fluency in both English and Japanese—spoken, reading, and writing—is required, along with CET-4 and JLPT N1 certification. Proficiency in MS Office and Windows is expected. Strong attention to detail, organizational ability, and effective communication skills are necessary to manage multiple tasks and support team objectives.
Benefits
This role offers the opportunity to contribute to global safety initiatives and support the development of life-saving therapies. You will work within a collaborative, mission-driven environment that values excellence, innovation, and patient impact. The organization fosters professional growth and emphasizes teamwork, shared purpose, and a culture where every individual plays a meaningful part in advancing healthcare solutions worldwide.
