ケースプロセシングスタッフ/ Case Processing Staff

A renowned pharmaceutical company is seeking a Case Processing Staff. The selected candidate will handle adverse event reporting and contribute to enhancing pharmacovigilance processes.

Responsibilities:

• Identify, interpret, and extract adverse event and all relevant corresponding case information from a wide variety of source documents
• Enter the extracted information into the global database for serious and non-serious AE/ADR case reports
• Identify information such as product technical complaints in the source documents
• Adhere to internal data entry standards and specific timelines
• Create and review comprehensive medical case narratives
• Verify trade names are correctly translated into INN (International Non-proprietary Name)
• Perform accurate coding of incoming serious and non-serious adverse events
• Enter drug-event relationship in non-serious and serious expected ADR/AE case reports as per company policies
• Contribute to continuous improvement of PV system and processes
• Ensure medical plausibility, consistency, and completeness of ADR case reports
• Request follow-up information for the completion of case reports making use of specific product/event-related questionnaires

Requirements:

• Bachelor’s degree or above in life sciences
• More than 2 years of Pharmacovigilance experience
• Practical experience in case processing
• Knowledge of ICH principles of SAE/AE reporting along
• Basic understanding of local and global regulatory rules and regulations
• Familiarity with safety policies and procedures in the major countries
• Understanding of AE and drug coding conventions (MedDRA, WHO-DD)
• Basic knowledge of standard office software packages (Word, Excel)
• Good medical/clinical interpretation skills
• Possess a valid authorisation to work in Japan
• Fluent level verbal and written Japanese and English (TOEIC 700+)

About the Company:

A multinational pharmaceutical organisation originating out of Europe that is responsible for the research and development of several widely recognised pharmaceutical products as well as products related to diagnostic imaging, women’s health and adhesives among others.

Keywords:

製薬, 薬剤処理スタッフ, 有害事象報告, 医薬品安全監視, 求人, 外資系

2068830/001