Jobs list of 8 - 17 million yen
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Job number: JN -072024-40050 Posted: 2024-09-25
【大阪】品質部門長（精密部品・コネクター）
大手取引多数／海外売上比率約70％10 - 13 million yen Osaka Industrial Quality Assurance / Quality Control
- Company overview
- Our client is a precision electronic components maker.
- Responsibilities
- ■業務内容
品質保証部門のトップとして、下記業務をお任せします。
品質保証部門の管理者として、製品の技術・品質に関する業務について管理すると共に、高度な案件については自ら参画して問題解決を図る。
当品質組織は、グローバルの品質部門直下となる。レポートラインであるグローバル品質トップ、および、当品質組織のマネジメント・その他本部と密接にコミュニケーションを取りながら業務を遂行する。
マネジメント範囲は、品質保証部門全体となる。（直雇用者41名）
担当する製品は全製品：ミニブレーカー（オリジナル商品）、コネクター・精密部品（OEM商品）
業務上、国内外の出張が発生する。
Takuya Kobayashi
Chemical -
Job number: JN -082024-172104 Posted: 2024-09-25
システム開発プロジェクトリーダー
ITプロジェクトの企画・導入経験をお持ちの方必見です。8 - 9.5 million yen Osaka Information Technology Embedded Engineer
- Company overview
- Our client is a manufacturer of elevators and escalators.
- Responsibilities
- 同社の自社システムの企画・運用管理に関わるプロジェクトリーダーを担当していただきます。現場担当者（海外法人含む）の課題解決のためシステムの企画・構築・導入
既存レガシーシステムに関するユーザサポートの実施
Yuhi Samejima
Consulting -
Job number: JN -072024-16095 Posted: 2024-09-25
【名古屋】国際税務業務 マネジャー
国際税務業務経験者必見です!8.76 - 10.76 million yen Aichi Consulting Accounting Consultant / Financial Advisory
- Company overview
- We, the Corporation, are a group of professionals specializing in taxation, providing tax advisory services to businesses and individuals. In particular, we assist our clients in developing tax planning, managing compliance, and assessing tax risk to support their legal and financial health. We also help clients develop optimal tax strategies by leveraging our expertise in domestic and international tax and regulatory systems. We utilize innovative approaches and data analysis to address complex tax issues and provide solutions tailored to our clients\' needs. We are also actively involved in strengthening community relations and educational outreach activities to help build a sustainable tax system.
- Responsibilities
- 日系企業向け国際税務業務:
日系企業の海外事業展開に関連する様々な税務問題を同社提携海外事務所と協働して解決するコンサルティング業務、コンプライアンス業務を提供しています。
クロスボーダー組織再編支援業務
クロスボーダーM&A支援業務（買収ストラクチャリング支援/税務デューデリジェンス支援）
買収後の統合に関する税務コンサルティング業務
グループ税務リスク診断
外国子会社合算税制、外国子会社受取配当益金不算入制度及び外国税額控除に関する国際税務コンサルティング業務
法人税申告書の作成又はレビュー業務
国税照会文書作成、税務調査対応の支援業務
外資系企業向け国際税務業務:
在日外資系企業に対する税務コンサルティング業務、コンプライアンス業務を提供しています。
海外親会社との取引に係る国際税務コンサルティング業務
法人税申告書の作成又はレビュー業務
海外親会社への報告パッケージのレビュー業務
Yuhi Samejima
Consulting -
Job number: JN -082024-171866 Posted: 2024-09-25
技術開発/事業創生
研究機関での電力システムに関する研究・開発経験（目安3年以上）をお持ちの方必見です。8.6 - 9.7 million yen Ibaraki Industrial Electrical Engineer
- Company overview
- We are a leading electronics company based in Japan, counted among the world\'s major manufacturers. Offering a wide range of products, we provide diverse solutions in fields such as energy, information, communication, automotive, healthcare, construction, finance, and services. We prioritize research and development, driving innovative technology and product development. Serving a broad spectrum of customers domestically and internationally, we contribute to the advancement of industries.
- Responsibilities
- 電力系統運用計画・制御を含むエネルギーマネジメント技術の研究開発をお任せします。
カーボンニュートラル達成に向けたレジリエンス向上と社会コスト低減を実現する製品・サービスの創生を目指します。
Yuya Migita
Electronics -
Job number: JN -072024-9932 Posted: 2024-09-25
【東京】ラインマネージャー（安全性部門／市販後PJT）
※在宅ベースで働きやすい環境8 - 14.5 million yen Tokyo Pharmaceutical Pharmacovigilance
- Company overview
- We are a global healthcare company and the largest provider of biopharmaceutical development and commercial outsourcing services. In today\'s rapidly changing environment surrounding the healthcare industry, we are making a significant contribution to the development of the industry through its four business segments: Clinical Development, Sales & Marketing, Investment & Alliances, and Consulting. The company, which has supported the development and commercialization of the top-selling drugs worldwide, plans to substantially increase the number of CRAs as it continues to increase projects in large-scale global studies, the anticancer field, the central nervous system field, and other rheumatology fields.
- Responsibilities
- PV事業部のオペレーション部門にてラインマネジメントをお任せします。ラインマネジャーはオペレーションスペシャリスト（PVスタッフ）の生産性向上がミッションです。市販後PJTは中国、インドのスタッフとも連携が必要になってくるため、英語を活かして働くことができます（通訳もいるため英語が流暢でなくても挑戦できます）。
■業務内容詳細：
・要員計画、業務配分、業務の指導などを通じて、担当するチーム（10~20名程度）のラインマネジメントを行う。
・メンバーとの定期的なコミュニケーションを通じて、サポーティブで働きやすい環境を実現・維持する。
・メンバーのパフォーマンス評価とキャリア開発を行う。
・他のマネージャーと協力して、プロジェクトのスケジューリング、要員計画、ピーク時のワークロードの予測を行い、プロジェクトの実
情を確認・評価・報告する。
・チームの作業プロセス、手順、およびインフラが継続的に改善されるようリードする。
・成果物の品質、タイムライン、コスト、生産性をモニタリングし、改善をリードする。
・メンバーのトレーニングニーズを特定し、トレーニングプランを策定・展開する。
Patrick Chang
Pharma -
Job number: JN -072024-38633 Posted: 2024-09-25
Environment promotion and Chemical substance management
Leading pharmaceutical company8 - 12 million yen Tokyo Support & Administration General Affairs
- Company overview
- We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.
- Responsibilities
- Formulation of the Group's Medium-Term Environmental Conservation Plan
Promote the PDCA cycle for the single-year plan to achieve the mid-term plan (promote the environmental management system)
Promotion of chemical substance handling management based on trends in global laws and regulations
Creation and management of SDS for chemical substances and support for risk assessment related to handling of chemical substances at sites
Audits of internal and business partners on environmental protection measures and handling and management of chemical substances
Planning and deployment of new plans based on the data of environmental conservation actvities.
Emmeline Tang
Electronics -
Job number: JN -072024-166901 Posted: 2024-09-24
経理（税務・管理会計）
上場企業（メーカー）で税務申告や開示・管理会計などの経理実務経験をお持ちの方必見です。11 - 16 million yen Osaka Accounting & Finance Accounts Payable / Accounts Receivable
- Company overview
- Our client is direct sales organization that develops and manufactures automation sensors, vision systems, barcode readers, laser markers, measuring instruments, and digital microscopes.
- Responsibilities
- 単体決算、連結決算
会計情報からの経営資料作成、情報発信
国内外グループ会社経理支援
各種税務申告、国際税務対応
決算短信・有価証券報告書・会社法計算書類等開示関連
Emi Iida
Corporate Services -
Job number: JN -072024-32783 Posted: 2024-09-24
【神戸】物流機器システム部のマネジメント職 ※国内シェアトップ／EC需要で業績好調◎／年休121日
物流機器メーカーでのSE実務経験をお持ちの方歓迎12 - 13 million yen Hyogo Industrial Product Development
- Company overview
- We are a logistics solutions provider in Japan and abroad. It primarily designs, develops, and implements automated logistics systems, providing innovative solutions to the manufacturing and distribution industries. We provide customized services tailored to our clients\' needs and support efficient logistics operations. We also offer environmentally friendly solutions with sustainability in mind, making us a leading company in the industry.
- Responsibilities
- ■業務内容：
情報系SE、制御系SEチームなどのマネジメント
■業務詳細：
メンバーがパフォーマンスを発揮できるように社内環境の構築
社内関係他部署との連携、協業
海外グループ会社とのグローバルプランの連携、協業
■入社後のイメージ：
まずは全体像を把握していただきます。
マネージャ― → 部長としてのキャリア構築となります。
直接会社の利益に貢献できる立場であり、将来的な技術を蓄積する部分でも会社としては重要なポジションです・
※経営会議等にも参加していただくことになります。
Takuya Kobayashi
Chemical -
Job number: JN -072024-19973 Posted: 2024-09-20
ADASソフト開発マネージャー
ADAS未経験もOK／自動車業界出身者必見9 - 12 million yen Kanagawa Automotive Embedded Engineer
- Company overview
- We provide products, services, and mobility technology related to automobiles. We offer technology and solutions to automobile manufacturers and related industries, supporting performance improvement, safety, and environmental considerations. Moreover, we focus on developing advanced technology and innovative products, positioning ourselves as one of the leading companies in the automotive industry. As an independent global supplier, we serve automotive and motorcycle manufacturers worldwide, consistently engaging in cutting-edge technology development. We can handle both domestic and international clients, expanding our opportunities to contribute globally.
- Responsibilities
- 顧客である自動車メーカーの要求に基づいた電子制御システムのシステム設計のマネージャを担当いただきます。自動車メーカーと直接コミュニケーションを取り、開発活動を推進する役割です。自動車メーカー(OEM)の車両制御機能に関する要求や当社独自の目標・要求に基づいたシステム設計（仕様定義、アーキテクチャ設計）
要求機能に応じた制御・論理設計、および機能安全・信頼性設計の構築。
SILS/実ECUを使用して、各機能の検証を行う。
OEMのスケジュールなどに基づいて開発活動を計画・調整し、開発・管理プロセスを含む成果のすべてを管理する。
全ての開発活動についてOEMと密なコミュニケーションをとり、問題・課題・懸念点の解決に参加する。
Misato Aiba
Electronics -
Job number: JN -072024-22406 Posted: 2024-09-20
Application Engineer
機械バックグラウンドお持ちの方、必見です！8 - 10 million yen Kanagawa Automotive Application Engineer / Sales Engineer
- Company overview
- We are a leading foreign technology company. A technology company with global operations, we provide advanced products and systems for automobiles, commercial vehicles and industrial technology. We contribute in particular to electrification technology, emissions reduction, climate protection, and safety. Serving markets as diverse as passenger and commercial vehicles, construction equipment, agricultural machinery, wind power, shipping, and rail technology, we are committed to sustainable mobility.
- Responsibilities
- Analysis of the given product specifications, requirements, and derivation of possible solutions in coordination with application design and core engineering. Product definition for the appropriate customer projects together with project management. Structuring of all arising design tasks and carrying out with design and testing. Determination of the necessary development capacities and – cost together with design, testing and prototyping. Well known and take responsible of design quality management tool for components and system like FMEA, FTA, DRBFM etc... Coordinate and lead customer design review of product development based on change points and failure mode. Negotiate and discuss design changes based on technical design background and test results review with customer. Clarification and definition of test plans for internal / external with the customer. Develop, prioritize, and supervise action items and close action items with strategic thinking in a global team environment for engineering. Lead and create technical presentations including test report and analysis to customer in cooperation with ZF global team members.
Rampo Higuchi
Automotive -
Job number: JN -072024-128616 Posted: 2024-09-20
Standard Cell Design Engineer/Tech. Manager
Pure Semiconductor R&D8 - 14 million yen Kanagawa Industrial Electrical Engineer
- Company overview
- Our Client is world\'s leading dedicated IC foundry.
- Responsibilities
- Define standard cell circuit requirement and complete design from schematic, layout and verification.
Conduct schematic design of deep-submicron CMOS technologies using industrial standard simulation tool, such as Hspice and/or Spectre.
Optimize circuit to achieve best PPA for their technology.
Path finding and innovation of circuit design for leading edge tech nodes.
Sub threshold voltage circuit design for IoT application.
Co-work with layout engineer to define architecture optimized for speed, power, and EMIR.
Yuya Migita
Electronics -
Job number: JN -072024-128617 Posted: 2024-09-20
Standard Cell Characterization Engineer/ Tech. Manager
Pure Semiconductor R&D8 - 14 million yen Kanagawa Industrial Electrical Engineer
- Company overview
- Our Client is world\'s leading dedicated IC foundry.
- Responsibilities
- Define and implement standard cell characterization methodology for leading edge technology.
Path finding and innovation of new cell and/or new feature characterization.
Define sub threshold voltage characterization for IoT application.
Develop best-in-class library characterization production flow to meet advanced customers’ requirement.
Communication with EDA tool vendor to resolve issues found in production.
Yuya Migita
Electronics -
Job number: JN -072024-128618 Posted: 2024-09-20
APR/Physical Design Engineer or Manager
Pure Semiconductor R&D8 - 14 million yen Kanagawa Industrial Electrical Engineer
- Company overview
- Our Client is world\'s leading dedicated IC foundry.
- Responsibilities
- Chip/Block level floorplan,
Clock tree synthesis,
Place & Route,
RC extraction,
STA, timing closure,
IR/EM analysis and fix,
DRC/LVS/ERC analysis and fix,
Tape-out sign off.
APR Flow development
Yuya Migita
Electronics -
Job number: JN -072024-128619 Posted: 2024-09-20
APR Engineer/Manager
Pure Semiconductor R&D8 - 14 million yen Kanagawa Industrial Electrical Engineer
- Company overview
- Our Client is world\'s leading dedicated IC foundry.
- Responsibilities
- Physical implementation of advanced technology chips.
Be responsible for chip implementation and signoff closure of customer’s projects or internal system test chips.
Be Familiar with design methodology development and innovation for advanced technology challenges.
Be responsible for advanced node PPA benchmark, and solution development.
Customer onsite/offsite supports will be required on demand.
Tape-out project management
Yuya Migita
Electronics -
Job number: JN -072024-149430 Posted: 2024-09-20
生産企画・生産管理
総合商社・専門商社・メーカーなどグローバルスコープでの業務経験のある方必見です10.26 - 16.74 million yen Tokyo Chemical Production Engineer
- Company overview
- Our client develops casual brands representing Japan.
- Responsibilities
- 担当商品において社内のMD、R&D部門と連携しながら商品開発及び生産管理全般を行って頂きます。
具体的には、どの工場に生産を依頼するかの検討、生産における縫製技術指導、素材の発掘から調達購買、条件交渉（品質、コスト、納期）、量産商品の生産管理（品質、納期）等を推進して頂きます。
扱う商品のロット数も非常に大きいため、取引先工場に設備投資を依頼することもあり、その場合は工場の経営計画まで踏み込んで折衝をすることもあります。
Yuya Migita
Electronics -
Job number: JN -082024-171141 Posted: 2024-09-20
Health Safety Environmental Manager
フランスに本社のあるメガエレクトロニクス製品メーカー10 - 12 million yen Tokyo Industrial Project Management
- Company overview
- This company is a French multinational corporation that specializes in energy management and automation solutions, spanning hardware, software, and services.
- Responsibilities
- The role of the “HSE Manager” is the to ensure everyone in our company complies to local authority Health, Safety and Environment regulations and company HSE directives. HSE manager will be responsible for establishing policies/procedures to maintain a safe workplace inside and outside of company for employees and contractors engaged by the company. As HSE manager you must have excellent communication skills and attention to detail in identify workplace hazards and risk. You will also be able to discover opportunities for improving work conditions and execute various HSE programs and best practices. The ability to communicate Health, Safety and Environment guidelines to a multidisciplinary workforce is essential. The goal is to ensure the workplace complied to legal regulations in local country, Company SAFE practices and Zero accident at all worksites. Main responsibilities:
Responsible for all Health Safety Environment (HSE) matters and ensuring the company complies to local legal regulations and business global safety and environment directives.
Ensures corporate HSE guidelines are implemented, updated, review of work procedures and sites auditing (for commercial office - SRs, Contractors & Project) in-accordance to local regulations and company HSE Systems
Organize Safety & Environmental training to ServicesRepresentativeｓ, Project managers and engineers, new hires and contractors for project kick-off on company requirement and compliance to local regulations.
Ensures Safety & Environmental training programs are being carried out to meet local regulations and Global Safety requirement, tracks, and report on numbers of training hours for Field Services and Project leaders.
Provide an effective Occupational Health and Safety (OH&S) program to improve the quality of work life and environment inside and outside. E.g., training, site audit to SRs and contractors, improvement programs etc.
Establish an effective action plan and procedures for monitoring the results of new HSE initiative and improvement action plan.
Supports all Business Units in HSE related matters and management system. E.g., participate and support in project sales, bidding, project safety discussion with project leader, organize periodic safety audit to monitor contractors safe work practices, attend to local authority inquiry and other related to HSE matters.
Review work method statement, risk assessment and Job Safety Analysis before submitting to customer for approval.
Assist procurement in contractor’s pre-qualification in 3rd party risk consultant / SSP-SRM.
Schedule customer site audit for Country CP, Service leader, Hub leader (minimum once a year leader or twice a year preferred.)
Monthly reporting of safe worked hour for commercial office (all headcount located in the office) include reporting of serious Near Misses, work-related accident and occupational illnesses to GlobES system.
Involve and lead accident/incident investigation, provides containment plan, short-term and long-term plan
Accountable for Business Continuity Plan (BCP) at country level.
Organize and lead Emergency Response Team for commercial office. Act as Single Point of Contact for office safety. E.g. liaise with landlord on fire drill, emergency drill, report on building defects to building facility, management office fire system such fire extinguishers, inspection of fire hose and evacuation route.
Ensure proper Health, Safety & Environmental Committee are in place and operated properly in accordance with local legal requirements.
Other Health, Safety & Environment initiative requested from region.
Di Fei
Energy/Construction -
Job number: JN -072024-8781 Posted: 2024-09-19
GME Account Manager - Japan
Efficient Production Role in Global Firm9 - 13.5 million yen Tokyo Chemical Sales Chemical
- Company overview
- We are the Japanese subsidiary of a European-based energy company, headquartered in the United Kingdom, with operations worldwide. Since entering the Japanese market, we have been strengthening our foothold and diversifying our business. Through partnerships with Japanese companies, we have seen growth in lubricant sales, petrochemicals, and other sectors. Our operations span across petrochemicals, trading, marine, industrial, and automotive lubricants. In our commitment to sustainable energy supply, we are not only involved in oil and natural gas but also in the development of clean energy and the reduction of carbon dioxide emissions.
- Responsibilities
- Supports a profitable portfolio of existing accounts (approx. 70% of time) and prospects in direct sales (approx. 30% of time), championing their Value Selling principles and the SmartGains framework to develop existing relationships with customers and deliver profitable growth via new customer acquisitions.
Participates in the development of local B2B business strategy, and regularly reviews the direct sales risk pipeline to maximise team profitability, assisting the team to maximise their effective time in attracting and retaining business.
Conducts sales activities such as volume and margin analysis, supporting tender activity, resolving customer operational issues and monitoring pricing performance integrity to enhance customer perception of value.
Drives new offers, building a deep understanding of the market, and actively supports prospecting activities, developing a pipeline of opportunities through more detailed customer analysis.
Supports the implementation of the GME in-year programmes and priorities. Aligns personal objectives and individual annual plans with Area Sales Manager to deliver results through implementation of in year programmes, offers, priorities as defined by the area annual plan (e.g. Smart Gains, New Builds, ancillary sales, price interventions etc.).
Clearly articulates product and services offers in a way that demonstrates distinctiveness and can translate this differentiation into customer value substantiated by customers’ willingness to pay a premium.
Prioritises personal resources and activities to enable effective strategy execution and demonstrable growth within existing customer accounts through acquiring new vessels/ assets and upselling/ cross selling (prioritised to strategic target sectors).
With input from Demand Control, develops and regularly updates detailed monthly customer forecasts, opportunities & vulnerabilities for the regional demand review which drives the LBM (Lubricants Business management) forecasting tool.
Spends at least 60% of time in front of customers and is able to navigate conversations across a diverse contact map at all levels and through all functions of the customer to build strong relationships that build trust, generate powerful insights and enable business growth.
Builds a robust plan to underpin each customer volume/ GM delivery and identifies areas to exploit further organic growth. Gains pricing approval through the pricing team (Net Tool).
Has a small portfolio of qualified prospects and works the pipeline drawing support from the Sales Operations Executive to manage Prospecting
Pipeline Management (PPM) KPIs in-line with targets.
Leads virtual customer account teams to meet customer needs drawing support from Customer Operations, Global Business Services (GBS), Demand Control and Technical Support teams including a clear delegation of responsibilities. Builds personal development plan (PDP) based on career plan and line manager coaching/ feedback.
Yuya Migita
Electronics -
Job number: JN -072024-150354 Posted: 2024-09-18
IT Infrastucture Manager | ITインフラマネージャー
有名テーマパークがリーダーシップを発揮できるITインフラMGRを募集しています！10 - 13.5 million yen Osaka Information Technology IT Management
- Company overview
- Our client operates theme parks.
- Responsibilities
- 業務内容：
インフラ運用設計チームの日常的な監督とリーダーシップを担当し、コアシステムのアップタイム信頼性を達成する
IDF、MDF、オンサイトデータセンターを含む施設のキャパシティプランニングと配置を行う
インフラのサブシステムとその信頼性に関する技術的リードおよびSMEとして活動する
施設内の音声およびデータ配信プラント全体において、システムの可用性を高いレベルで維持するため、新しいテクノロジーを査定する
新規または既存のテクノロジーソリューションの強化、アップグレード、実装に関連するプロジェクトにSMEとして参加する
光ファイバーおよび構内配線ソリューションを含む、配線および技術設備ソリューションを見積もって実装し、これらのシステムのサポートを担当する社内およびサードパーティのチームと調整する
リソースの必要性、必要なスキルセット、部門構成を継続的に評価し、当企業の成長需要や条件に対するとチームの整合性をはかる。
リソースを監督し、機会や課題についてインフラ部門シニアマネージャーと協議する
ビジネスパートナーとの協力関係を築き、維持する
チームを代表し、担当ビジネスパートナーとの窓口になる
当企業のインフラストラクチャーオペレーションを代表して社内の関係者と協力する
必要に応じて、コントラクターやチームメンバーに技術的なリーダーシップや指示を提供し、セカンドレベルのサポートを行う
その他指示された業務の遂行
Mizuki Ishii
Inhouse IT -
Job number: JN -082024-173844 Posted: 2024-09-18
プロダクトマネージャー
要件定義書、外部設計書などのソフトウェア仕様書作成経験をお持ちの方必見です。8 - 10 million yen Tokyo Information Technology IT Management
- Company overview
- The company is engaged in real estate business and IT service business for real estate operators.
- Responsibilities
- プロダクトマネージャーとして、自社SaaS型サービスの改善・拡張をお任せします。データ連携機能における現状課題の整理現在のデータ連携プロセスやシステムの課題を分析し、改善のための優先順位を決定します。
データ連携機能における改善要望の管理利用者や関係者からの改善要望を収集・整理し、プロダクトバックログとして管理します。
データ連携機能における開発計画の策定プロダクトのロードマップに基づき、データ連携機能の開発計画を作成します。
データ連携機能の開発計画に沿った開発プロジェクト要件の定義開発チームと協力して、具体的な開発プロジェクトの要件を定義し、仕様書を作成します。
要件の開発からリリースまでのエンジニア・QAの支援要件定義から開発、テスト、リリースまでの各フェーズで、エンジニアリングチームやQAチームをサポートし、円滑なプロジェクト進行を支援します。
Hideo Shirakigawa
IT Online -
Job number: JN -072024-34137 Posted: 2024-09-18
PV Manager
Pharma業界の方歓迎10 - 13 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- We are the Japanese subsidiary of a leading U.S. company in the pharmaceutical and healthcare industry, offering a wide range of products. We provide high-quality and high-performance products and services that cover a broad spectrum from diagnostics to treatment, including diagnostic drugs and devices, pharmaceuticals, hospital products, and nutritional supplements. We have earned high praise for our offerings. Naturally, there is also interdepartmental mobility and information sharing, which helps us maintain our overwhelming position as a comprehensive healthcare manufacturer.
- Responsibilities
- Manage the collection, processing and assessment of safety related information as it relates to the company's Nutrition products in compliance with applicable regulatory requirements and guidelines, as well as division and corporate level policies and procedures; Ensure the pharmacovigilance (PV) system for the company's Nutrition products registered as drugs in Japan is in place and is compliant with regulatory standards; Maintain the PV IT system used for adverse event reporting. The manager is considered a subject matter expert in the area of pharmacovigilance.
Main responsibilities:
Manage the Japan PV team (through guidance and supervision) in the collection, review, and assessment of adverse event reports/safety related information
Ensure submission of reportable adverse events to the health authority in accordance with requirements and timeframes outlined in local regulations
Develop and maintain local standard operating procedures that are aligned with corporate/division level policies and procedures and follow local regulations
Develop and provide PV training for new/junior team members and local affiliate staff
Serve as the point of contact for all local PV activities, inquiries and issues, including responding to inquiries from the health authority
Prepare and submit periodic reports to the health authority in compliance with local regulations
Conduct internal inspections of the PV system as required by local regulations
Serve as the PV lead during internal audits and external inspections; prepare and execute CAPAs for any PV related findings
Participate in the review of promotional materials
Act as the safety database administrator, including coordinating maintenance and upgrades of the PV IT system
Manage vendor and process associated with searching of scientific literature for safety related information
Participate/collaborate with the Medical Safety & Surveillance team on global safety/pharmacovigilance related initiatives and goals
Functions independently as a decision-maker within specified parameters and decisions could potentially have financial ramifications or impact brand reputation, regulatory compliance, or patient and product safety.
Individual is recognized as an internal subject matter expert and resource with responsibilities that require high level critical thinking and analytic abilities.
Leads cross-functional projects related to the area of expertise with a high level of visibility across the local affiliate site.
Responsible for ensuring compliance with local regulatory requirements related to pharmacovigilance for Japan’s drug products.
Shotaro Tsubaki
Medical Device