ファーマコビジランススペシャリスト/ Pharmacovigilance Specialist

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.

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
• Prepare PMDA submission reports and generate PMDA XML files using the designated ICSR Creation Tool when required
• Maintain submission documentation and ensure compliance with reporting timelines
• Apply local product labelling information to adverse event cases using approved product labelling documents
• Collaborate with Team Leads and cross-functional teams to support operational activities
• Provide status updates and progress reports to the Operations Manager
• Complete assigned activities on time while maintaining quality and productivity standards
• Support process improvement initiatives and operational efficiency
• 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
• Experience reviewing and processing adverse event reports
• 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
• Overseas education or study-abroad experience

About the Company:

A global professional services and technology company helping organisations modernise their technology, transform business processes and create better customer experiences. Its Japan operations provide consulting, digital engineering, AI, cloud, software, data and cybersecurity solutions across industries, supporting businesses in driving digital transformation and sustainable growth.

Keywords:

ファーマコビジランス, 医薬品安全性, 安全性情報, ケースプロセシング, ケースアセスメント, 臨床開発, 医薬品業界, 日英バイリンガル, 求人, 外資系

Job Ref: GAKVI1