非公開
We are seeking a detail-oriented and motivated Pharmacovigilance Specialist to support safety case processing, case assessment review, and PMDA reporting activities for global pharmaceutical clients. The successful candidate will be responsible for evaluating adverse event reports, performing J-Assessments, managing safety data within Argus/Argus J, and ensuring compliance with regulatory requirements and quality standards.
This role requires strong pharmacovigilance knowledge, attention to detail, and the ability to work effectively in a fast-paced, client-focused environment.
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.
グローバルな環境が特徴の企業です。