SERM Manage(Safety evaluation & Risk management section manager)

Site Name: Japan - Tokyo - Akasaka Posted Date: Jan 26 2023 職務の目的および主な業務内容 Job Purpose & Key Responsibilities SERM Managerとして、以下に示す業務についてティーチング、コーチングにより部下を指導し部下のスキルアップ、育成に責任を持つ。 管理職として業務管理、予算管理、勤怠管理、人的リソース管理等の一般管理職業務を取り仕切る。 SERM Groupとしては、GSK Japanが承認取得した医薬品（Pharma製品、Vaccine製剤）及び医療機器を、医療従事者及び患者さんが常に安全・安心・適正に使用できるように、実臨床下で使用された際に得られる安全性情報及び関連する情報を評価・分析する。その結果に基づき、これら製品が良好な安全性プロファイルを維持するための種々の安全対策をGlobal Safety/Medicalチームと議論し立案・実行する。 この活動を通じてGlobal Safetyの一員として全世界の患者さんの安全性を確保し、GSK製品のライフサイクルマネジメントに貢献する。 GSK製品（医薬品及び医療機器）の安全性情報の評価 収集された症例情報、文献・学会情報、措置情報を随時及び計画的（1~12カ月単位等）に評価・分析する。この際、検討計画を予め定め、適時の計画見直しを行う。具体的な方法は以下の通り。 傾向分析、定性・定量評価（Spotfire等の可視化ツールを活用） 医療リアルワールドデータ（JMDC、MDV等）、コマーシャル部門/メディカル部門から得られる市場情報やmVOC、諸外国の開発/市販後安全性データ、同種同効薬情報の活用、バリューエビデンスアウトカム部門との協働 国内外社内医師やGlobal Safety/Medical部門との議論 GSK製品の安全対策の立案及び実施（リスクマネジメント） 上記評価・分析結果（データ）及び医療環境等の外部環境を勘案した、医療従事者及び／又は患者さん向けの安全対策を立案・実施する。代表的な安全対策事例は以下のとおり。 新医薬品等に対する市販直後調査［EPPV］（上市6か月間の集中的な安全対策・リスクコミュニケーション）の企画・推進及び報告書の作成 医療従事者向け情報提供資材の作成、患者向け情報提供資材の作成 添付文書（使用上の注意）の改訂の周知徹底資材の作成 1及び2の活動に関連するもの 医薬品リスク管理計画（RMP：Risk Management Plan）の作成及び維持管理 GSK製品において注視すべき安全性リスク及びその設定、更には必要となる安全性監視活動及び該当リスク最小化活動を纏め、医療従事者と規制当局に対する当社のコミットメントの作成、改訂 上記に係る当局照会事項対応 再審査申請（市販後4～10年の安全性・有効性評価の集大成）及び申請までの定期業務 上市後半年又は1年単位での定期報告書作成及び当局照会事項対応 上市後3-9年後までに収集した全安全性情報の精査結果を取りまとめた再審査申請資料の作成及び当局照会事項対応 収集した安全性情報に関する薬機法に基づく規制当局への報告書作成 As a SERM Manager, educate and guide subordinates through teaching and coaching for the following tasks. Responsible for improving and developing subordinates. Perform general managerial duties such as budget management, subordinates’ working time management, human resource management, etc. For ensure patient safety in global safety, safety evaluation and risk management group evaluate and analysis the safety information and related information obtained when GSK products (Pharma and Vaccine products, medical devices) are used in clinical practice for used safely, securely and properly. For ensure keeping favorable safety profile, commit safety evaluation and risk management activities collaborate with global safety/medical team, contribute to life cycle management of GSK products. Safety data evaluation of GSK products (Pharma and Vaccine products, medical devices) Evaluate and analyze safety information (cases, literatures and overseas measures) appropriately and systematically (1 to 12 months, etc.). At this time, review plan will be documented in advance and the plan will be reviewed in a timely manner. Trend analysis, qualitative / quantitative evaluation (using visualization tools such as Spotfire) Utilization of real world data (JMDC, MDV, etc.), market information and mVOC obtained from commercial / medical division, development / post-marketing safety data from other countries, information of similar medicine, collaboration with value evidence outcomes division Collaboration and discussions with internal / external physicians and Global Safety / Medical departments Planning and implementation of safety measures for GSK products (Risk Management) Plan and implement safety measures for healthcare professionals and / or patients in consideration of the above evaluation / analysis results (data) and the external environment such as the medical environment. Safety measures are not limited to but including Planning and promotion of EPPV (Early Post-marketing Phase Vigilance): intensive safety measures and risk communication for 6 months after launch and preparation of reports. Preparation of information provision materials for HCPs and patients Preparation of material for package insert revision Other Safety activities Preparation and maintenance of risk management plan (RMP) RMP summarizes the safety risks that should be watched for GSK products, the rationale for setting risks, and pharmacovigilance plan and applicable risk minimization activities. This is commitment to HCPs and regulatory authorities. Correspondence to the authority’s inquiry related to RMP Reexamination application (collection of safety / efficacy evaluation for 4 to 10 years after marketing) and periodic report until re-examination Submission of periodic reports and respond to inquiries on a 6monthly or annual basis Preparation of reexamination dossier that summarizes all safety information collected within 3-9 years after launch and response to inquiries Preparation and submission of a report to the regulatory authority based on the Pharmaceutical and Medical device Act. 必要要件 Required Skill, Experience, Etc. 必要な条件Basic Qualification スキル Skill グループ単位以上の組織マネジメントスキル 自部署の目標設定能力 コミュニケーション、コーチング、アジリティー能力 Organization management skills (group or department) Ability to set goals for own organization Ability about communication, coating and agility 経験 Experience 実務担当者としての安全対策業務（RMP、集積検討、安全性定期報告、再審査申請、市販直後調査等）の経験 医薬品のファーマコビジランス業務における、グループ単位以上の組織マネジメント経験（3年以上） 海外ステークホルダーとの業務経験 Experience for safety evaluation, risk management, J-PSUR, Re-examination and EPPV as PV staff More than 3 years experience for organizational management (group level or more) regarding pharmacovigilance for pharmaceutical drugs Experience for working with foreign stakeholders 学位/資格/語学力 Education/certification/Language ライフサイエンス系学位　学士以上 英語力（海外担当者との口頭でのコミュニケーションができるレベル） Life science degree, bachelor's degree or above English skill (verbal communication) 望ましい条件 Preferred Qualification 経験 Experience 製薬協等の業界活動の経験 Experience for industry organization activity, e.g. JPMA 要件を一部満たしていない場合でも、当該業務に強い意欲がある方からのご応募をお待ちしております。 GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.