Location: Japan (Remote / Hybrid possible)
Employment type: Full-time
Salary: Competitive, based on experience
Benefits: Full social insurance, paid leave, remote work options, international training opportunities
勤務地: 日本(リモート/ハイブリッド応相談)
雇用形態: 正社員
給与: 競争力のある給与(経験・能力に応じ決定)
福利厚生: 社会保険完備、有給休暇、在宅勤務制度、国際的な研修機会
Role Summary
Focus on local literature screening in Japan, with additional PV support tasks
Opportunity to act as a primary or secondary project lead depending on assignment
Collaborate with the Team Leader and Manager to manage risks related to quality, timelines, and client communication
Contribute to internal process improvements and additional PV activities
職務内容
- 国内文献スクリーニング業務を中心としたPV活動のサポート
- プロジェクトによっては、プロジェクトリード(プライマリまたはセカンダリ)を担当
- チームリーダーやマネージャーと連携し、品質・納期・クライアント対応に関するリスク管理
- 内部手順の改善活動や、追加PV業務のサポート
Responsibilities
- Enter and update information in the validated literature screening system (LITSIS)
- Prepare journal lists and search strategies
- Perform literature screenings and redact personal identifiable information (PII)
- Forward valid case safety reports, manage acknowledgements, and ensure filing
- Prepare and share literature screening reports with clients
- Maintain reference product information (e.g., SmPC, PIL)
- Oversee and support vendor-managed local literature screenings when applicable
- Bachelor's degree or higher in medical, biomedical, or biotechnology sciences
- At least 1 year of experience in safety/pharmacovigilance in pharma or CRO
(or recent graduate with relevant education) - Fluency in Japanese and English (spoken and written)
- Proficiency in MS Office
- Based in Japan
主な業務内容
- 医薬品安全性情報(症例報告)の処理・管理
- 文献スクリーニングおよび評価(規制要件やクライアント要件に準拠)
- 症例のトリアージ、追跡調査、クエリ対応
- データ入力、ナラティブ作成、重篤性・因果関係・予測可能性の評価
- 品質管理チェック、症例の突合・整合性確認
- 定期的なリスト作成、レポート作成
- 社内手順書の改訂や改善への貢献
- Bachelor's degree or higher in Life Sciences
- At least 1 year of experience in pharmacovigilance / safety within pharma or CRO (or recent graduate with relevant education)
- Proficiency in both Japanese and English (written & verbal)
- Skilled in MS Office
- Based in Japan
- Strong analytical and problem-solving skills
- Detail-oriented and highly organized
- Ability to work efficiently under pressure
- Excellent planning, time management, and reporting skills
- Innovative thinker with ability to handle multiple tasks
- Strong analytical and problem-solving abilities
- High attention to detail and accuracy
- Ability to perform well under pressure and tight deadlines
- Excellent planning, time management, and reporting skills
- Innovative mindset with ability to handle multiple tasks
主な業務内容
- 文献スクリーニングシステム(LITSIS)への入力・更新
- ジャーナルリストや検索戦略の準備
- 文献スクリーニングおよび個人情報(PII)の適切な処理
- 有効な症例報告の送付、受領確認、文書管理
- クライアントへの文献スクリーニングレポート作成・共有
- 製品情報(SmPC、PIL等)の維持管理
- ベンダー管理下でのローカル文献スクリーニングのサポート
- 医学・バイオメディカル・バイオテクノロジー系の学士号以上
- 製薬業界またはCROにおける安全性・PV業務経験1年以上
(または関連学位を持つ新卒者も可) - 日本語・英語の読み書き・会話に堪能な方
- MS Officeの実務スキル
- 日本在住の方
- 分析力と問題解決能力に優れた方
- 正確で細やかな業務遂行ができる方
- プレッシャーの中でも効率的に働ける方
- 計画力、タイムマネジメント能力が高い方
- 新しい視点で課題解決に取り組める方
- Competitive salary (based on skills & experience)
- Full social insurance coverage (health, pension, employment, accident)
- Paid annual leave
- Hybrid/remote work options available
- Career growth in an international setting
- 競争力のある給与(経験・スキルに応じて決定)
- 社会保険完備(健康保険・厚生年金・雇用保険・労災保険)
- 有給休暇制度あり
- ハイブリッド/リモートワーク相談可
- 国際的な環境でのキャリアアップのチャンス
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