Pharmacovigilance Specialist

Job Description

Appealing Points:

• Specialize in Pharmacovigilance & Drug Safety: Manage safety case assessments, adverse event processing, and PMDA reporting while working with industry-standard tools such as Argus and Argus J.
• Develop Expertise in Japanese Regulatory Compliance: Gain hands-on experience with J-Assessments, PMDA submissions, regulatory documentation, and Japanese pharmacovigilance requirements in a highly regulated environment.
• Contribute to Patient Safety on a Global Scale: Collaborate with cross-functional teams to ensure timely, high-quality safety reporting, drive process improvements, and support global drug safety operations.

Annual Salary: 4 Million Yen and above

Job Responsibilities:

• Safety Case Processing & Assessment
  • Receive and review safety case reports from multiple sources, including healthcare professionals, medical representatives, call centers, clinical trials, post-marketing surveillance programs, literature, and other reporting channels.
  • Perform case assessment and review activities in accordance with client requirements, SOPs, and regulatory guidelines.
  • Conduct duplicate case searches and reconciliation activities as required.
  • Open, process, and maintain safety cases routed through the global safety database/system.
  • Ensure accurate and complete data entry within Argus and Argus J.
• J-Assessment & PMDA Reporting
  • Perform J-Assessments in Argus J in accordance with Japanese regulatory requirements.
  • Prepare and generate PMDA submission reports outside of Argus when required.
  • Generate PMDA submission XML files using the designated ICSR Creation Tool for cases where PMDA reports cannot be generated directly through Argus J.
  • Maintain submission-related documentation and ensure compliance with reporting timelines.
  • Apply local product labeling information for each adverse event by referring to approved product labeling documents.
• Operational Excellence
  • Collaborate closely with Team Leads and cross-functional teams to support operational activities.
  • Provide status updates and progress reports to the Operations Manager as required.
  • Ensure timely completion of assigned activities while maintaining quality and productivity standards.
  • Support process improvement initiatives and contribute to operational efficiency.
  • Maintain compliance with client, regulatory, and internal quality requirements.

Job Qualification

• Minimum 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.

Preferred Qualification:

• Minimum 2 years of Pharmacovigilance experience within a global pharmaceutical company, CRO, or healthcare organization.
• Experience with Japanese Pharmacovigilance regulations and PMDA reporting requirements.
• Experience performing J-Assessments and managing regulatory submissions.

Langauge Requirements: Native level Japanes (JLPT N1 or higher) and Business level Japanese

Company Description:

One of the world's leading professional services companies, transforming clients' business, operating, and technology models for the digital era. 
Their unique industry-based, consultative approach helps clients envision, build and run more innovative and efficient businesses. 
Headquartered in the U.S., this company is one of the Fortune 500 companies and is consistently listed among the most admired companies in the world.

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