募集要項
- 募集背景
- A global technology services company is looking for a Pharmacovigilance Specialist (Japanese Bilingual). The selected candidate will assess adverse event reports, perform J-Assessments, manage safety data in Argus and Argus J, support PMDA reporting, and maintain compliance with regulatory and quality requirements.
- 仕事内容
-
A global technology services company is looking for a Pharmacovigilance Specialist (Japanese Bilingual).Responsibilities:
* Receive and review safety case reports from healthcare professionals, medical representatives, call centres, clinical trials, post-marketing surveillance, literature, and other sources
* Assess and review safety cases in accordance with client requirements, SOPs, and regulatory guidelines
* Conduct duplicate case searches and reconciliation activities
* Open, process, and maintain safety cases in the global safety database
* Ensure accurate and complete data entry in Argus and Argus J
* Perform J-Assessments in Argus J in accordance with Japanese regulatory requirements
* Maintain compliance with client, regulatory, and internal quality requirements
Requirements:
* Bachelor's degree or equivalent in Life Sciences, Non-Life Sciences, Pharmacy, Medicine, Allied Health Sciences, or a related healthcare discipline, or a Nursing qualification/licence
* More than 1 year of experience in Case Assessment Review, Safety Case Processing, or Pharmacovigilance operations
* Experience working with safety databases such as Argus or Argus J
* Native level Japanese (JLPT N1); business level English (TOEIC 700+)
Preferred requirements:
* More than 2 years of experience in Pharmacovigilance within a global pharmaceutical company, CRO, or healthcare organisation
* Experience with Japanese Pharmacovigilance regulations and PMDA reporting requirements
* Experience performing J-Assessments and managing regulatory submissions
- 応募資格
-
- 必須
-
More than 1 year of experience in Case Assessment Review, Safety Case Processing, or Pharmacovigilance operations
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- Up to JPY6400000 per annum
