Job Description
Job Title:
Pharmacovigilance (PV) Associate
Location:
Japan
Focus:
Pharmaceuticals
Role Overview
A regulated pharmaceutical organisation is seeking a Pharmacovigilance (PV) Associate to support its drug safety and pharmacovigilance operations in Japan. This role is responsible for supporting the local pharmacovigilance system, ensuring timely processing of adverse events, safety surveillance, and compliance with Japanese and global regulatory requirements.
The position plays a key operational role in maintaining patient safety, regulatory compliance, and high-quality safety data across marketed products.
Key Responsibilities
1. Adverse Event (AE) Case Processing
- Monitor and receive Individual Case Safety Reports (ICSRs) via the PMDA ICSR Reception Site
- Review, assess, and process adverse event reports related to pharmaceuticals (and, where applicable, medical devices)
- Ensure timely and accurate submission of ICSRs to PMDA in accordance with regulatory timelines
- Collect and process AE information from multiple sources, including healthcare professionals, patients, and literature
- Perform follow-ups to obtain additional or missing case information
- Prepare and manage XML files for regulatory submissions
- Submit applications and XML data via PMDA systems
- Maintain accurate documentation and compliance records
2. Data Entry & Quality Control
- Enter case data accurately into pharmacovigilance databases
- Perform MedDRA coding verification for reported adverse events
- Conduct quality checks to ensure data consistency and regulatory compliance
3. Medical Literature Monitoring
- Conduct routine literature searches using recognised Japanese literature services
- Document search results in tracking tools
- Identify relevant safety signals and escalate findings appropriately
4. Systems, Processes & Documentation
- Maintain and update internal project trackers to ensure real-time visibility of case status and deliverables
- Support the development and maintenance of work instructions and SOPs
- Perform QC of pharmacovigilance and regulatory documentation
5. Communication & Cross-Functional Coordination
- Respond to internal inquiries related to safety data
- Coordinate closely with Safety Management and cross-functional stakeholders
- Participate in team meetings and provide updates on case handling and workload
6. Regulatory Reporting & Compliance
- Support preparation and submission of regulatory safety reports, including ICSRs and periodic safety reports, in line with PMDA requirements
- Support quality control and translation of pharmacovigilance and regulatory documentation
7. Medical Information Support
- Support medical information activities, including call intake where required
- Review, update, and maintain medical information materials
- Support development and review of PI, RMP, and IF documentation
Candidate Profile
- Bachelor's degree or higher in Pharmacy, Medicine, Life Sciences, or a related discipline
- Minimum of 3 years' experience in pharmacovigilance, drug safety, or a related regulatory function
- Familiarity with Japanese pharmacovigilance systems and tools used for ICSR preparation, signing, and submission
- Strong understanding of Japanese regulations (GVP, GPSP) and global safety guidelines (ICH, FDA, EMA)
- Experience working with pharmacovigilance databases and safety surveillance activities
- Strong attention to detail with excellent organisational and time-management skills
- Native-level Japanese (written and verbal preferred)
- Strong written English skills
Reporting & Collaboration
- Reports to Pharmacovigilance leadership in Japan
- Works closely with internal stakeholders including Regulatory Affairs, Quality Assurance, and Medical Affairs
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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