Job Description
Job Description: Title:
Pharmacovigilance Associate
Department:
Drug Safety / Pharmacovigilance
Reports To:
Pharmacovigilance Manager
Location:
Tokyo Japan
Position Overview
The Pharmacovigilance (PV) Associate is responsible for supporting the pharmacovigilance system to ensure compliance with both local and global regulatory requirements. This position involves the collection, evaluation, and reporting of adverse events, as well as assisting with safety surveillance and regulatory submissions. The goal of the role is to maintain high standards of patient safety and regulatory compliance.
Key Responsibilities
2. Data Entry and Quality Control
3. Literature Surveillance
4. System and Workflow Management
5. Cross-functional Coordination
6. Regulatory Reporting and Compliance
- Adverse Event (AE) Case Management
- Receive, review, and process adverse event reports from various sources (healthcare professionals, patients, literature, etc.).
- Ensure timely submission of Individual Case Safety Reports (ICSRs) in accordance with applicable regulatory timelines.
- Enter and maintain case data in pharmacovigilance systems or databases.
- Conduct follow-ups to obtain additional details for reported cases.
- Maintain accurate documentation for all safety-related activities and submissions.
- Ensure all case data are entered accurately into the safety database.
- Verify proper medical coding for adverse events (e.g., MedDRA).
- Perform quality checks and ensure consistency with regulatory standards and internal procedures.
- Perform routine literature searches to identify relevant safety information.
- Document search results in internal trackers and report any significant findings.
- Contribute to signal detection and trend analysis activities when applicable.
- Maintain internal project trackers and case-handling documentation.
- Ensure real-time updates of case progress and report completion.
- Liaise with internal departments such as Regulatory Affairs, Quality Assurance, and Medical Affairs.
- Support communication with internal stakeholders regarding safety data and reporting obligations.
- Participate in internal team meetings and contribute to performance updates.
- Support timely preparation and submission of ICSRs and periodic reports (e.g., PSURs) in compliance with local and international pharmacovigilance regulations.
- Ensure adherence to Good Vigilance Practice (GVP) and other applicable regulatory frameworks.
Qualifications
- Bachelor's degree or higher in Pharmacy, Medicine, Life Sciences, or a related discipline.
- Minimum 3–5 years of relevant experience in pharmacovigilance, drug safety, or regulatory affairs.
- Familiarity with electronic case processing tools and pharmacovigilance databases.
- Strong understanding of Japanese and global pharmacovigilance guidelines (e.g., GVP, GPSP, ICH).
- Excellent organizational, analytical, and communication skills.
- Strong time management skills and ability to meet tight deadlines.
- Proficiency in Japanese (native or near-native) and English (written).
Reporting and Collaboration
- Reports directly to the Pharmacovigilance Manager.
- Works closely with cross-functional teams, including Regulatory Affairs, Quality Assurance, and Medical Affairs.
Additional Information
- Must maintain confidentiality and adhere to data protection and compliance standards.
- May require participation in team meetings, audits, or inspections as assigned.
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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