Pharmacovigilance Specialist

Why This Role Matters

Pharmacovigilance is central to patient safety, regulatory compliance, and maintaining the benefit-risk profile of medicinal products throughout their lifecycle. In markets such as Japan, strict regulatory oversight by the Pharmaceuticals and Medical Devices Agency requires precise, timely, and compliant safety reporting.
This role ensures high-quality case processing, regulatory submissions, literature surveillance, and compliance monitoring aligned with global and Japanese pharmacovigilance requirements. By supporting expedited reporting, ICSR compliance, and regulatory database management, the position plays a direct role in inspection readiness and maintaining trust with Health Authorities and business partners.

Job Description

The Japanese Pharmacovigilance Specialist is responsible for executing drug safety activities including case processing, regulatory reporting, literature search and review, compliance tracking, and coordination with Japanese-speaking stakeholders.
The role requires strong knowledge of global and Japanese pharmacovigilance regulations, hands-on safety database experience, and the ability to communicate effectively in both English and Japanese.

Key Features of the Role

• End-to-end involvement in ICSR case processing and compliance activities
• Exposure to Japanese regulatory requirements and PMDA pharmacovigilance activities
• Interaction with global and Japanese-speaking PV teams
• Participation in audits, inspections, and compliance metric tracking
• Involvement in regulatory database lifecycle management
• Contribution to literature surveillance and signal support activities

Responsibilities

General Pharmacovigilance Activities

• Maintain working knowledge of adverse event safety profiles, labeling documents, client guidelines, SOPs, and global safety regulations
• Ensure compliance with internal and regulatory timelines for adverse event reporting
• Assist in development of project-specific safety workflows and templates
• Participate in audits and inspections and support follow-up activities
• Monitor performance metrics and ensure compliance with client-defined standards
• Liaise with client stakeholders to ensure delivery of high-quality work
• Mentor new team members when required
• Archive source documents and relevant communication appropriately

Case Processing

• Monitor incoming safety reports from mailboxes, EudraVigilance, literature searches, and other sources
• Perform triage for completeness, validity, and medical consistency
• Create and process cases in the safety database
• Perform accurate data entry in accordance with SOPs and client guidelines
• Ensure correctness of expectedness, seriousness, and causality assessments
• Perform MedDRA coding as per “MedDRA Term Selection: Points to Consider”
• Conduct follow-up activities and query management
• Draft medically cohesive case narratives
• Perform quality and validation checks before workflow progression
• Support reconciliation activities with Data Management teams
• Generate line listings and tabulations for periodic and ad hoc safety reports
• Investigate late ICSRs and document corrective actions
• Generate and reconcile compliance metrics

Drug Safety Reporting

• Perform quality control of case reports and safety submissions
• Maintain local and global reporting requirements
• Register and manage electronic reporting with relevant authorities
• Coordinate submissions to regulatory authorities, ethics committees, and investigators
• Track submission status and maintain documentation
• Perform unblinding of SUSARs where applicable
• Collaborate with global PV teams for requirement collection

Regulatory Affairs Support

• Maintain and update regulatory databases with product lifecycle changes
• Create applications, regulatory events, variations, and references in regulatory systems
• Support EU region procedures including National, Centralized, Mutual Recognition, and Decentralized processes
• Validate SmPC data and perform xEVMPD submissions via EMA Gateway
• Generate marketing authorization status reports

Literature Search and Review

• Develop and maintain search strategies based on client-defined parameters
• Retrieve, review, and process literature citations
• Identify valid cases and enter into safety database
• Maintain local journal listings
• Perform quality checks on search strategies
• Monitor database thesauri updates and implement necessary revisions

Required Qualifications

• Strong knowledge of drug safety and drug development processes
• Ability to interpret and apply global safety regulations
• Understanding of regulatory submission processes
• Proficiency in safety databases and literature search tools
• Strong analytical and problem-solving abilities
• Client-focused and quality-driven approach

Educational Requirements

• Degree in Life Sciences, Health Sciences, Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, or related discipline
• Degree in Medicine, Dentistry, Physiotherapy, Nursing, or similar healthcare field is advantageous

Experience and Skills

• Experience in pharmacovigilance or drug safety activities preferred
• Good knowledge of medical terminology
• Experience with PMDA pharmacovigilance requirements
• Experience working with Japanese-speaking PV case processing teams
• Proficiency in English (written and spoken)
• Japanese language proficiency – JLPT N2 or above (mandatory)
• Strong communication and interpersonal skills
• Excellent organizational and prioritization abilities
• Ability to manage multiple tasks independently
• Strong IT proficiency including MS Office and web-based systems

Salary Insights

• Compensation varies based on PV experience, Japanese language proficiency level, and regulatory exposure
• Candidates with PMDA reporting experience and JLPT N2 or higher certification typically fall within mid-to-senior compensation brackets
• Bilingual PV professionals often command competitive salary premiums due to specialized market demand

Company Overview

Organizations operating in global pharmacovigilance environments collaborate with international regulatory bodies including the Pharmaceuticals and Medical Devices Agency and the European Medicines Agency to ensure compliance with safety reporting standards.
This role supports adherence to global and Japanese safety regulations while maintaining high standards of quality and inspection readiness.

FAQs

• Is Japanese language proficiency mandatory?
Yes, JLPT N2 or higher certification is required.

• Is PMDA experience necessary?
It is strongly preferred, particularly for Japan-focused pharmacovigilance activities.

• Does the role involve case processing?
Yes, hands-on case processing and compliance monitoring are core responsibilities.

• Will the role involve regulatory submissions?
Yes, electronic reporting and lifecycle regulatory updates are included.

Application Tips

• Highlight PMDA reporting experience and Japanese PV exposure
• Mention JLPT certification level clearly on your resume
• Emphasize hands-on safety database experience
• Showcase examples of compliance metric tracking or late case investigation
• Demonstrate ability to manage bilingual communication in safety operations