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PV Associate (Pharmacovigilance).
Toranomon 40MT Builings, 7th Floor, 5-13-1 Toranomon, Minato-ku Tokyo, Tokyo N/a JP
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
- 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
- Conduct routine literature searches using recognised Japanese literature services
- Document search results in tracking tools
- Identify relevant safety signals and escalate findings appropriately
- 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
- 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
- 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
- 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
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Reports to Pharmacovigilance leadership in Japan
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Works closely with internal stakeholders including Regulatory Affairs, Quality Assurance, and Medical Affairs
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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