【AstraZeneca】【GBS-PS】Case Intake Advisor

Japanese follows English

Job Profile

The Case Intake Advisor is responsible for receiving, assessing, and accurately entering safety information from multiple source types relating to AstraZeneca & Rare Disease Unit (RDU) pharmaceutical products.  Working closely with both internal and external stakeholders, this role ensures that adverse event (AE) case processing meets Japanese regulatory requirements and AstraZeneca standards.  The Case Intake Advisor is an essential contributor to pharmacovigilance compliance, patient safety, and quality standards, serving as the operational backbone for the intake and initial data handling of Individual Case Safety Reports (ICSRs). 

The Local Case Intake Advisor will be fluent in Japanese as well as capable in basic English listening and reading (see Essential). 

The role will support activities of the GBS-PS function and work under the guidance of Case Intake Team Managers.  Expectation is to deliver routine activities independently, resolve moderate scope and complexity problems, and conduct interactions consistent with company values and compliance standards. 

Core responsibilities may include: 

• Intake, preliminary assessment, and accurate recording of safety data and Individual Case Safety Reports (ICSRs) for local cases (both AstraZeneca and RDU products), including phone calls with reporters 

• Confirm completeness and accuracy of case data before further processing 

• Identify and assure correct handling of personal information (PII), and other confidential data, per regulatory guidelines 

• Timely and compliant data entry into relevant safety database (Global Safety database) 

• Collaborate with internal stakeholders (e.g., Medical Information, Regulatory Affairs, Quality; refer to Key Relationships) to clarify, complete, or triage case information 

• Flag urgent or reportable cases for escalation or expedited processing 

• Follow SOPs for filing and archiving safety documentation to achieve audit readiness 

• Support responses to Health Authority (PMDA) queries on intake cases as required 

Accountabilities & Responsibilities

• Handle local case intake of adverse events, ensuring full compliance with GVP, AstraZeneca internal guidelines, and Japanese regulatory requirements 

• Implement and support team to perform Corrective and Preventative Actions in the event of local non-compliance and process completed late logs 

• Ensure accurate and timely data capture, extraction, and entry in safety database systems, in accordance with the relevant global / Japan regulations and procedural guidance 

• Execute routine quality checks on individual case data for completeness and data integrity at intake stage 

• Perform reconciliations ensuring the accuracy of pharmacovigilance data that is transferred and received 

• If required, undertake manual follow-up disseminating clear and accurate information 

• Request follow-up information for the completion of case reports making use of specific product/event-related questionnaires when necessary 

• Contribute to audit and inspection-readiness activities and documentation practices, and support regulatory authority inspections 

• Complete all required training and maintain up-to-date expertise on applicable regulations and procedures 

• Maintain knowledge of Japanese product portfolio and regulation changes relevant to safety reporting, including Japan regulatory authority regulations, global and Japan procedural and guidance documents 

• Support ICSRs processing and handling, including adverse event reporting (both AstraZeneca and Rare Disease Unit products) 

• Assist with Health Authority interactions for ICSR-related queries 

• Contribute to effective operational implementation of the Quality Management System appropriate to the GvP discipline 

• Collaborate on PV aspects related to Organised Data Collection Programmes, Digital and Social Media activities, and partnerships with external parties 

• Per process/project needs, perform Peer review and any ad-hoc project specific tasks and activities as assigned  

• If required, perform literature search and related activities for AZ product portfolio 

• If required, review, assess and process safety data and information received from various sources; distribute reports and/or metrics onwards to both internal and external third parties following applicable regulations and standard operating procedures (SOPs), under guidance and support of the appropriate Local Case Intake Team Managers and/or senior team members 

• Performs other related duties as assigned or requested per business needs 

Essential Education, Qualifications, Skills, and Experience

• Degree Qualified 

• Japanese language proficiency Test (JLPT): N2 or higher 

• English language proficiency in listening and reading: A2 Waystage based on Common European Framework Reference for Languages (CEFR) 

• 1–2 years of experience in local data entry in a safety database 

• Effective communication and reading proficiency in Japanese; ability to understand source documentation 

• High attention to detail and ability to identify personal/confidential information (PII) 

• Cross functional collaborative approach 

• Effective and lateral thinking  

• Problem solving 

• Excellent written and verbal communication skills 

職務概要

ケース受付アドバイザーは，アストラゼネカおよびRare Disease Unit（RDU）医薬品に関連するさまざまな情報源から安全性情報を受領・評価し，正確に記録する責任を担います．本職務は，社内外のステークホルダーと連携しながら，有害事象（AE）症例処理が日本の法規制およびアストラゼネカ基準を満たすことを確実にします．ケース受付アドバイザーは，PVコンプライアンス，ペイシェントセイフティー，品質基準の維持・向上に不可欠な役割として，個別症例安全性報告書（ICSR）の受付および初期データ管理の業務基盤を担います． 

ローカルケース受付アドバイザーには，日本語の流暢さと，英語の基礎的なリスニング及びリーディング能力が求められます．本職務はGBS Patient Safety部門の活動を支援し，ケース受付チームマネージャーの指導下で業務を遂行します．日常的な業務を自律的に推進し，中程度の範囲や複雑さを持つ課題も対応可能であること，また企業の価値観やコンプライアンス基準に則した業務対応が期待されます． 

主な職務内容としては，以下を含みます． 

• 国内症例（アストラゼネカ及びRDU製品）の安全性データ並びにICSRの受付，初期評価，正確な記録および通報者との電話対応 

• ケースデータの完全性と正確性の確認 

• 規制ガイドラインに基づいた個人情報（PII）その他の機密データの適切な取扱い確保 

• グローバル安全性データベース等，関連データベースへの迅速かつ適切なデータ入力 

• 必要に応じて，医療情報担当，薬事，品質管理など社内関係部門と連携し，症例情報の精査・補完・選別 

• 迅速な対応や報告が必要な症例の早期段階での識別およびエスカレーション 

• 監査対応を目的とした安全性文書の整理・保管に関するSOP遵守 

• 必要に応じて，症例受付業務に関する規制当局（PMDA）からの問い合わせ対応 

職務詳細

• 有害事象に関する国内症例の受付業務の遂行（GVP，アストラゼネカ社内ガイドライン，ならびに日本の法規制の完全遵守） 

• 日本で規制遵守に不備があった場合の是正・予防措置の実施及びチーム支援、遅延記録処理の実施 

• 関連するグローバル／日本の規制と手続きガイダンスに則り，安全性データベースシステムへの正確かつ迅速なデータ取得・抽出・入力 

• 症例受付段階における個別症例データの完全性・データ整合性に関する定常的品質チェックの実施 

• 薬剤安全性情報（ファーマコビジランスデータ）の授受に対する照合作業の実施 

• 必要に応じた手作業によるフォローアップと，わかりやすく正確な情報提供 

• 症例報告の完成のため，必要に応じて医薬品や事象に特化した質問票等を活用した追加情報の依頼 

• 監査・査察対応準備活動および関連文書管理への貢献，規制当局による査察の支援 

• 必須研修の履修及び関連規制・手続きに関する最新知識の維持 

• 日本国内製品ポートフォリオ及び安全性報告に関連する法規制変更（規制当局・グローバル及び日本管理文書・ガイダンス含む）の把握 

• ICSRの処理・管理，及び有害事象報告（アストラゼネカ・Rare Disease Unit対象）への対応 

• ICSR関連の規制当局対応支援 

• GVP領域に適した品質管理システムの効果的な運用への貢献 

• 組織的データ収集プログラム，デジタル・ソーシャルメディア活動，外部パートナーとの協働におけるPV関連業務への参画 

• 業務・プロジェクトの必要性に応じたピアレビュー実施及び臨時プロジェクト課題等への対応 

• 必要に応じた文献検索および関連業務の実施 

• 必要に応じて，複数情報源から受領する安全性データのレビュー・評価・処理，及び関連報告書・指標の社内外第三者への配布（適切なローカルケース受付チームマネージャー及びシニア担当者の指導・支援下で，適用法規及びSOP遵守） 

• 事業上必要に応じたその他関連業務の遂行

必要なスキル、経験、資格

• 学位取得 

• 日本語能力試験（JLPT）N2以上 

• 英語リスニング・リーディング能力（CEFR A2 Waystage相当） 

• 安全性データベースにおけるローカルデータ入力業務経験（1～2年） 

• 日本語での効果的なコミュニケーション能力と読解力，原資料の理解力 

• 高い注意力と個人情報・機密情報（PII）の識別能力 

• 部門横断的な協働姿勢 

• 効果的かつ多角的な思考力 

• 問題解決能力 

• 優れた文章および口頭でのコミュニケーション能力 

Date Posted

16-Oct-2025

Closing Date

30-Jan-2026

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.