【AstraZeneca】【GBS-PS】Patient Safety Quality Reviewer at AstraZeneca

, , Japan -

Full Time

Start Date

Immediate

Expiry Date

14 Jan, 26

Salary

0.0

Posted On

16 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Japanese Language Proficiency, English Language Proficiency, Pharmacovigilance, Quality Control, Regulatory Compliance, Data Clarification Request, Communication Skills, Attention to Detail, Problem Solving, Collaboration, Audit Preparation, Case Processing, Literature Search, Mentoring, Operational Implementation, Safety Reporting

Industry

Pharmaceutical Manufacturing

Description

Japanese follows English Perform narrative review and request corrections and/or updates for clinical clarity, context, and GVP alignment Implement or support the team to perform Corrective and Preventative Actions in the event of local non-compliance or regulatory feedback Where necessary, 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 Apply robust QC procedures, including DCR (Data Clarification Request) where necessary Adhere to internal data entry standard in accordance with the relevant global / Japan regulations and procedural guidance Complete or oversee the final approval process prior to submission to regulatory authorities Contribute to audit and inspection-readiness activities and documentation practices, and support regulatory authority inspections Responsible for taking phone calls with PMDA, Medical Representatives, and/or physicians as needed 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 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 職務概要品質レビューの担当者は，アストラゼネカおよびRare Disease Unit医薬品におけるIn-Line QCチェックや，J-GVP規制の担当責任者としてGVPコンプライアンス承認，PMDAへの安全性データの提出準備等を担います．本職務では，個別症例安全性報告書（ICSR）や関連資料のデータ精度，ナラティブの質，規制当局対応準備が最高水準になるように管理します．社内チームと密に連携して，安全性データ品質やPVプロセスに関するローカルエキスパートとして活動し，PMDAなど日本の規制当局対応にも参加します．本業務担当者は，日本語が堪能で，英語の基礎的なリスニング・リーディング・ライティング能力も求められます．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のもと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．すべてのICSR（日本国内・海外症例を含むアストラゼネカ・RDU医薬品）の品質レビュー J-GVP適合承認，及びPMDA提出用資料の承認原資料やナラティブを科学的な正確さ・コンプライアンスを確保しながら解釈ケース受付，薬事及び安全性データベース担当者と積極的にコミュニケーションし，食い違いや不明点を解消最新のPV関連規制，ケース処理基準，PMDAの動向の理解を維持必要に応じて，PMDA，MR，医師との電話対応若手スタッフの症例処理品質基準のメンタリング SOPに準拠した安全性文書のファイリング・保管を行い査察対応体制を維持職務詳細ナラティブのレビュー，臨床的な明瞭さ・文脈・GVP基準に沿った修正依頼日本で規制遵守に不備があった場合や規制フィードバックがあった場合，是正・予防措置（CAPA）の実施及びチーム支援必要に応じて，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 DCR（データ確認依頼）などのQC手法の適用グローバル／日本の基準・手順に則った社内データ入力ルールの遵守規制当局への提出前承認の完了あるいは監督監査・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要に応じてPMDAやMR，医師との電話対応必須研修の受講及び関連法規・手順についての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 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）N1又は日本語母語話者，優れた日本語文章能力英語リスニング・ライティング・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ケース処理の確たる実績日本のPV関連法規，GVP／GCPに関する高度な知識高い注意力，品質志向日本語及び英語によるDCRプロセス・文書作成における円滑なコミュニケーション部門横断的な協働姿勢効果的かつ多角的思考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 is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

The Patient Safety Quality Reviewer is responsible for conducting quality reviews of individual case safety reports and ensuring compliance with Japanese GVP regulations. This role involves collaboration with internal teams and communication with regulatory authorities to maintain high standards of safety data quality.