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Pharmacovigilance Associate
Job Description
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
1. 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.
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.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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