Jobs list of Pharmaceutical

Lung Cancer Medical Affairs Associate / Up to 21M

A highly productive work environment

10 - 21 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: This company is the world\'s leading pharmaceutical company.
Responsibilities: MAIN REPONSIBILITIES:
Contribute to the development and implementation of a product strategy as a core member of the Product Team by conducting medical strategy and delivering medical and scientific advice both internally and externally to ensure that the short and long term business goals of assigned products are achieved and that the interests of the customer and company are safeguarded.
Ensure implementation of appropriate global and Japan medical strategies into actions by acting as an interface with regional and global asset and marketing colleagues
*Non-manager gain support from Sr. Manager to fulfil responsibilities
Execute Medical plan to meet unmet medical needs related to products in the assigned area
Create Medical Plan in the assets in collaboration with Therapeutic area Medical Team Lead.
Execute some part of Medical Plan in the assigned area such as medical advisory board meeting, publication, promotional documents review in collaboration with Therapeutic Area Medical Team Leads.
Provide information on customer’s feedback on product development and life cycle strategies to related divisions/department in the company.
Support promotional document review in collaboration with Therapeutic area Medical Team Lead
Support medical/scientific education to MRs in disease areas.
Medical & Scientific communication (Meet domestic/ global medical KOLs and provide/exchange scientific information)
Establish a good and highly reliable relationship through non-promotional activities such as scientific exchanges (e.g. discussion using latest research papers and follow-up of contents of academic conference presentations) with domestic top-level medical KOLs in the assigned area.
For creating Medical Plan, acquire extensive medical/pharmaceutical information and gather latest medical information in the assigned area.
In response to UMR (Unsolicited Medical Request: spontaneous request for medical information), provide accurate, high-quality and unbiased information to important customers, stakeholders and medical relevant colleagues.
Medical & Scientific communication (Meet domestic KOLs and provide/exchange scientific information)

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【港区】RA/QA／医療機器の申請・承認や認証の管理など◆

グローバル企業の日本法人

6 - 8 million yen Tokyo Pharmaceutical Regulatory Affairs

Company overview: Top tier medical device company globally.
Responsibilities: 【血液ガス分析装置など世界トップクラスのシェアを持つ製品を扱うグローバル企業の日本法人】
■業務内容：
RA/QAとして、IVDおよび医療機器の新製品登録や、承認・認証・登録の保守、監査の対応などをご担当いただきます。
【変更の範囲：会社の定める業務】
■具体的な業務内容：
＜規制関連業務＞
新製品の申請書類の準備と提出、問い合わせ対応、承認の取得をスケジュール通りに実施
海外メーカーとの連携をしながら、臨床試験のプロトコルを作成し、提出
臨床試験が必要な新製品の許可（証明）を取得
E3/E2カテゴリーの申請書類の準備と払い戻しポイントの取得
部分的な変更や修正のための申請書類の準備と提出、問い合わせ対応、承認の取得
外国メーカーライセンスの登録、更新、維持
現地での営業許可証の更新、維持
基準、規制、適用要件の収集、レビュー、トラッキング
製造施設に対するQMSコンプライアンス調査申請書の準備とQMS適合証明書の取得
パッケージインサートやラベルなどの規制文書の準備と改訂の管理
日本語のラベル、インサート、SDSのレビューと管理
規制の観点から広告資料や顧客情報のレビュー
規制に関するトレーニングを実施
規制文書の開示業務をサポート
輸入書類の作成を支援

＜品質保証＞
品質管理システムの文書作成と改訂
品質管理システムの改善と維持
内部監査と外部監査を実施
製品の受入検査としてのQCテストを実施
顧客への調査報告書の作成
ヘルプラインへの全ての問い合わせをレビューし、週次のGVPミーティングを実施

創薬研究職

創薬における実務経験のある方必見です

8.2 - 10.4 million yen Kanagawa Pharmaceutical Research & Development

Company overview: Our client conducts research and development of novel pharmaceutical products.
Responsibilities: 同社のプラットフォーム技術と早期臨床開発分子のパイプラインを拡大するために、熱意と高いモチベーションを持った人材を募集しています。分解活性を有するdegrader分子の設計と合成を担当し、医薬品化学プロジェクトをリードしていただきます。適切な薬物様特性を持つdegrader分子の設計、合成、および特性評価
社内会議での議論に積極的に参加し、成果を発表を行う
社内外の幅広い研究者とのコラボレーション
プロジェクトのスケジュールと目標に合わせた実験の設計と実行
有機合成、医薬品化学、創薬の科学的、技術的な背景を広く認識する

アカウントマネジメントダイレクター

CROで営業の経験をお持ちの方必見です

8.7 - 15 million yen Tokyo Pharmaceutical Sales / MR

Company overview: We are a global leader in biopharmaceutical development based in the United States.
Our client is a CRO giant, offering a wide range of services supporting clinical trials at every and all stages. They also provide specialized services for biotech-related clinical trials, leveraging their unique technology and industry expertise.
Our services span the entire spectrum of clinical development, from planning and execution to monitoring and data management. Additionally, we offer advice on pharmaceutical regulation and market deployment, supporting clients through the process from drug approval to market entry.
Responsibilities: 営業提案書の作成、レビュー
市場動向調査および競合他社情報の収集
過去入札情報などの収集と案件獲得のための戦略立案・交渉
受託後のガバナンス統制（ローカル及びグローバルチームの一員として）
グローバルとの連携など

Dermatology Medical Manager

A highly productive work environment

10 - 17 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: This company is the world\'s leading pharmaceutical company.
Responsibilities: JOB POSITION PURPOSE
The MA role family comprises a variety of medical scientific specialties, such as BU Medical and field based Medical.Be the company medical scientific point of contact for HCPs, medical societies, regulators, academia and other external stakeholders.Maintain the highest scientific standards, independence and compliance in every medical/scientific external activity, as well as in scope internal processes.
MAIN RESPONSIBILITIES:
Collaborate with medical stakeholders as a scientific expert for HCPs, medical societies, academia, and other relevant organizations.
Establish a strong collaborative scientific relationship through non-promotional activities such as scientific exchanges (e.g., discussion using the latest research papers and follow-up of contents of academic conference presentations) with relevant stakeholders in dermatology.
Develop and maintain a comprehensive stakeholder map to identify relevant HCPs, medical societies, and other relevant external stakeholders to communicate effectively and agilely at an expert level.
Handle UMR (Unsolicited Medical Request) responses, provide accurate, high-quality, and unbiased information to relevant external experts and HCPs as allowed by company policies and sharing customer viewpoints with company as appropriate.
Follow up clinical investigator-sponsored research and medical grants compliant with company policies.
Acquire extensive medical/pharmaceutical information and gather the latest medical information in the assigned area as a scientific matter expert.
Deliver key medical and scientific activities within the medical plan, e.g., high-quality educational materials, generation of real-world evidence, non-interventional studies, database studies and registries (in collaboration with the Health & Value team) and ensure timely publication of data.
Demonstrate medical and scientific leadership and expertise
Provide and exchange medical/ scientific information for/from medical institutions (and other related sources) in the assigned area and from stakeholders.
Drive for heightened understanding of the clinical and medical attributes of our products in order to enhance the safe and efficacious use.
Maintain the highest scientific standards during in/ external activities to provide deep medical and scientific expertise.
Contribute to the implementation of local medical strategies and life cycle clinical plans for inline and pipeline medicines / vaccines to address unmet medical needs and fill data gaps.
Make important contributions to decisions of medical strategies for assigned products, in order to ensure safe, proper, and effective use of assigned products. These activities contribute to patients (and populations) health and well-being and to healthcare professionals from a medical, and pharmaceutical perspective, and potentially to clinical study needs and design.
Contribute to achieving the department/team goals, and/or participate in cross-organizational projects as a core member and provide guidance to deliver the results.
Play an active role in supporting members in the team/organization with the line manager to move towards its goals
Develop and execute the medical plan aligned with the medical strategy to meet unmet medical needs in the assigned product(s) and therapeutic area(s) in collaboration with office medical
Identify unmet medical needs and healthcare disparities in the assigned asset(s) and therapeutic area(s) through medical activities such as advisory board meetings and scientific exchanges with HCPs and other relevant individuals and organizations.
Create an activity plan as Medical with senior Medical management to address the needs and fill data gaps.
Develop a Customer Facing Medical Plan in the therapeutic area(s) and asset(s) to establish collaborative scientific relationships with stakeholders.
Execute the Customer Facing Medical Plan in the assigned area(s) / asset(s) such as unbiased medical and scientific communication with HCPs, medical advisory board meetings, educational seminars, and data generation initiatives, medical materials creation, and necessary scientific input.
Provide subject matter expertise and high-quality scientific exchange, bringing insights into the organization to help shape strategy.

Establish a highly reliable, long-term relationship with stakeholders.
Establish deep and enduring peer-to-peer scientific relationships with leading HCPs and specialists, including non-traditional partners and key decision makers.
Maintain and enhance the cross-BU alignment on metrics
Ensure to collect necessary information and analyze insights prior to the meetings in order to provide deep medical and scientific expertise to stakeholders and HCPs
For identifying unmet needs and healthcare disparities as well as contributing to the medical strategy, acquire extensive medical/ pharmaceutical information in the assigned area.
Provide feedback on information and views obtained from stakeholders and HCPs, for related relevant department in the company, and consolidate them as Medical/ Public Health/ Healthcare insights.
Enhance opportunities for creation of evidence based on medical needs by sharing issues in the medical field with internal/ external stakeholders through constructive and cross-functional partnership based upon scientific and medical excellence
Optimize patient centricity of medical communications and deliverables, incorporating Health Literacy and cultural awareness principles to ensure that patients remain the ultimate focus
Align, contribute, and collaborate with relevant internal stakeholders
Provide information on expert / HCP / relevant others feedback on product life cycle strategies to related divisions/departments in the company.
Collect and analyze unmet medical needs and seek solutions in collaboration with cross functional colleagues in the company.
Scientific input for scientific meetings and materials.
Provide medical education programs with and to relevant stakeholders.
Observe the code of conduct, company’s regulations, and compliance, appropriate communication with related departments, and exercise leadership.
Conduct activities in compliance with the MHLW Guidelines for Prescription Drug Sales Information Activities.
Ensure activities and communications are conducted in compliance with all policies, guidelines, and regulations.
Ensure awareness of responsibility for reporting adverse events
For all company products, observe applicable laws/regulations and the company policy, and “Gather and report safety information*”. At an appropriate timing, attend training programs on obligation of assigned safety reporting.

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Hematology Medical Affairs Senior Manager

充実したキャリア支援制度／生産性高く働ける環境

10 - 21 million yen Tokyo Pharmaceutical Medical Affairs

Company overview: This company is the world\'s leading pharmaceutical company.
Responsibilities: The MAS role family comprises a variety of medical scientific specialties, such as office Medical (oMAS) and field Medical scientist (fMAS).Be the company medical scientific point of contact for HCPs, medical societies, regulators, academia and other external stakeholders.Lead and develop a team of fMAS to maintain the highest scientific standards, independence and compliance in every medical/scientific external activity, as well as in scope internal processes with collaboration with office MAS. Main responsibilities:
People DevelopmentGuide and develop members in order to contribute to optimization of product values from the scientific point of views
Contribute to developing team members through appropriate assignments, coaching, appropriate appraisal and constructive feedback
Effectively manage through and lead the change in an evolving healthcare environment
Collaborate effectively and demonstrate leadership and teamwork with peers, internal stakeholders and external customers that inspires alignment and partnership on a shared vision or strategy

Demonstrate medical and scientific leadership and expertiseProvide and exchange medical/ scientific information for/from medical institutions (and other related sources) in the assigned area and from stakeholders.
Drive for heightened understanding of the clinical and medical attributes of our products in order to enhance the safe and efficacious use.
Maintain the highest scientific standards during in/ external activities to provide deep medical and scientific expertise.
Contribute to the implementation of local medical strategies and life cycle clinical plans for inline and pipeline medicines / vaccines to address unmet medical needs and fill data gaps.
Make important contributions to decisions of medical strategies for assigned products, in order to ensure safe, proper, and effective use of assigned products. These activities contribute to patients (and populations) health and well-being and to healthcare professionals from a medical, and pharmaceutical perspective, and potentially to clinical study needs and design.

Develop and execute the medical plan aligned with the medical strategy to meet unmet medical needs in the assigned product(s) and disease area(s) in collaboration with office medicalIdentify unmet medical needs and healthcare disparities in the assigned asset(s) and disease area(s) through medical activities such as advisory board meetings and scientific exchanges with HCPs and other relevant individuals and organizations.
Create an activity plan as Medical with senior Medical management to address the needs and fill data gaps.
Develop a Customer Facing Medical Plan in the assigned disease area(s) and asset(s) to establish scientific peer level professional relationships with stakeholders.
Execute the Customer Facing Medical Plan in the assigned area(s) / asset(s) such as unbiased medical and scientific communication with HCPs, medical advisory board meetings, educational seminars, and data generation initiatives, medical materials creation, and necessary scientific input.
Provide subject matter expertise and high-quality scientific exchange, bringing insights into the organization to help shape strategy.

Collaborate with medical stakeholders as a scientific expert for HCPs, medical societies, academia, and other relevant organizations.Establish a strong collaborative scientific relationship through non-promotional activities such as scientific exchanges (e.g., discussion using the latest research papers and follow-up of contents of academic conference presentations) with relevant stakeholders in the assigned area.
Develop and maintain a comprehensive stakeholder map to identify relevant HCPs, medical societies, and other relevant external stakeholders to communicate effectively and agilely at an expert level.
Handle UMR (Unsolicited Medical Request) responses, provide accurate, high-quality, and unbiased information to relevant external experts and HCPs as allowed by company policies and sharing customer viewpoints with company as appropriate.
Follow up clinical investigator-sponsored research and medical grants compliant with company policies.
Acquire extensive medical/pharmaceutical information and gather the latest medical information in the assigned area as a scientific matter expert.
Deliver key medical and scientific activities within the medical plan, e.g., high-quality educational materials, generation of real-world evidence, non-interventional studies, database studies and registries (incollaboration with the Health & Value team) and ensure timely publication of data.

Establish a highly reliable, long-term relationship with stakeholders.Establish deep and enduring peer-to-peer scientific relationships with leading HCPs and specialists, including non-traditional partners and key decision makers.
For identifying unmet needs and healthcare disparities as well as contributing to the medical strategy, acquire extensive medical/ pharmaceutical information in the assigned area.
Provide feedback on information and views obtained from stakeholders and HCPs, for related relevant department in the company, and consolidate them as Medical/ Public Health/ Healthcare insights.
Enhance opportunities for creation of evidence based on medical needs by sharing issues in the medical field with internal/ external stakeholders through constructive and cross-functional partnership based upon scientific and medical excellence
Optimize patient centricity of medical communications and deliverables, incorporating Health Literacy and cultural awareness principles to ensure that patients remain the ultimate focus

Align, contribute, and collaborate with relevant internal stakeholdersProvide information on expert / HCP / relevant others feedback on product life cycle strategies to related divisions/departments in the company.
Collect and analyze unmet medical needs and seek solutions in collaboration with Medical Affairs HQ colleagues and cross functional colleagues in the company.
Scientific input for scientific meetings and materials.
Provide medical education programs with and to relevant stakeholders.

Observe the code of conduct, company’s regulations, and compliance, appropriate communication with related departments, and exercise leadership.Conduct activities in compliance with the MHLW Guidelines for Prescription Drug Sales Information Activities.
Ensure activities and communications are conducted in compliance with all policies, guidelines, and regulations.

Ensure awareness of responsibility for reporting adverse eventsFor all company products, observe applicable laws/regulations and the company policy, and “Gather and report safety information*”. At an appropriate timing, attend training programs on obligation of assigned safety reporting.

As neededContribute to Business Development in the assigned area(s): In collaboration with Japan Medical Lead, Japan Medical Affairs Product Lead, Global MA members and other members from relevant functions, identify unmet medical needs and candidate therapies for potential medical interventions in the assigned disease area(s) in Japan through medical activities such as advisory boards and consultations with medical experts while keeping confidentiality.
Rapidly respond to critical supply issues from the medical perspective (e.g., rapid communications with academic societies and regulatory authorities)

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品質保証｜東証プライム上場大手医療機器メーカー

医薬品や医療機器の品質保証部門での業務経験をお持ちの方必見です

7 - 8.5 million yen Shizuoka Pharmaceutical Quality Assurance / Quality Control

Company overview: We are a leading Japanese manufacturer and distributor of medical devices and related products. We have a particularly strong reputation in the field of medical devices, such as catheters and artificial heart-lung machines, and we are expanding our business widely both domestically and internationally. We are also expanding into the fields of pharmaceuticals and blood systems, providing comprehensive medical solutions. We focus on innovation and quality control, and develop our products with patient safety and healthcare professionals\' convenience in mind. We aim to contribute to the development of healthcare from a global perspective and are actively involved in the realization of a sustainable society.
Responsibilities: 同社は5万点以上の製品を160以上の国と地域に展開している総合医療機器メーカーです。2023年度は過去最高の売上収益・営業利益・当期利益額を更新し、売上高1兆円規模も目前に迫っています。
同社において、工場における品質保証担当を増員募集します。現在工場におけるGMP/QMSの維持管理業務のボリュームが増加しており、特に製品品質照査業務は、法的要求である医薬品だけでなく、顧客要求事項から医療機器への展開も必要となっている背景から、品質文書経験をお持ちの方をお迎えしたい考えです。独自の技術力によって各製品群で高シェア率を獲得しており、医療現場への影響力の大きい企業で、次のキャリアを築きませんか？
■業務内容：
製品品質照査（品質文書レビュー）業務：製造記録や品質試験記録から得られる管理指標が1年を通して安定しているかトレンド的な視点で評価し、報告書を作成します。
変更管理業務
文書管理業務

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海外営業

法人営業のご経験が活かせます。

5 - 7 million yen Tokyo Pharmaceutical Sales / MR

Company overview: -
Responsibilities: 担当顧客への定期訪問
業務に慣れていただいた後に、未開拓の国や製品に関する新規開拓もご担当いただく予定です
顧客のニーズ把握に伴う商品サービスのプレゼン、為替を踏まえた値段交渉、見積書の作成
販売契約内容の確認、締結
顧客への納品、または納品の確認
自社内の開発、製造部門への指示出し

医薬品の安全監視策、およびリスク最小化策の立案、実施

グローバル人材を積極的に採用しております。

8 - 12 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: We are a leading biotechnology company focusing on cutting-edge technologies. Our key areas of focus include cancer, kidney disease, and immune disorders. In the field of antibody medicine, we are committed to developing innovative new drugs by combining technologies such as the "Potelligent technology" (which enhances antibody activity by 100 times) and "Human Antibody-Producing Mouse." We are dedicated to establishing a global research and development framework to provide medicines to a large number of patients.
Responsibilities: 市販薬および治験薬の安全性管理業務（安全性監視計画の立案、安全性評価（シグナル評価）、RMP策定、添付文書改訂など安全確保措置の策定・実施など）
規制当局との対応業務（承認申請資料作成、定期報告作成、再審査申請資料作成、照会事項、適合性調査など）
グループ会社担当者（海外含む）と連携した活動（電話会議、メール連絡、海外出張など）

ファーマコビジランス職（症例評価）

安全性評価業務経験者（3年以上）をお持ちの方必見です。

6 - 12 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.
Responsibilities: 安全性評価に関わる業務
安全性評価に係る案件に関するグローバル関係者（社内外）との協議、業務の推進
安全管理情報のデータ収集および症例評価プロセスの管理
運用に関するグローバル関係者（社内外）との協業

【東京】セイフティオペレーションマネージャー（スタッフ or シニアスタッフ）

PVに関連する業務経験3年以上ある方必見

5.5 - 9 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: Our client is a leading global pharmaceutical firm with a presence in about 150 countries and a workforce of around 40,000 employees. The company is dedicated to advancing healthcare through innovative treatments across various therapeutic areas.

In Japan, the firm employs over 2,500 professionals focused on delivering solutions tailored to the specific needs of the local population. By integrating global advancements with local insights, the company collaborates closely with healthcare providers to ensure effective and accessible therapies.

Committed to sustainability and corporate responsibility, the firm strives to improve patient outcomes and enhance the quality of life. Its efforts make significant contributions to both the local and global healthcare landscape.
Responsibilities: ヘルスケアに関する製品およびサービスの提供を行う当社において、安全性情報に関わる下記業務をご担当いただきます。
業務詳細：
・ファーマコビジランス部門と協力し、個別症例処理業務を行っているベンダー管理（進捗管理、リソース確保および品質維持）
・上記に係る手順書の作成および改訂
・安全性データベースをアップグレードなどによるプロセス変更の影響を評価し、プロセスを改善および構築する
・同社内のクロスファンクショナルなプロジェクトやタスクフォースのプロジェクトマネジメント
・オペレーションスペシャリストとしてのDXなどを組み込んだ同社における効率的なプロセス構築、改善の実施

【東京】グローバルファーマコビジランス職（業務品質管理、査察・監査管理担当）

グローバルでのPV業務経験者歓迎

6 - 11 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.
Responsibilities: ■業務内容：グローバル安全管理ユニットの業務品質のモニタリング、継続改善業務、PV業務品質管理体制の基盤構築業務
国内/海外の規制当局や提携会社、自社監査部門等によるPV関連の査察・監査の対応業務、提携会社のリスク調査対応業務、査察・監査対応業務の基盤構築業務

■キャリアパス：担当業務の即戦力として、実務経験を積むと共に、当社に対する理解を深める。
当人の適性を踏まえ、OJTやジョブローテーション等を活用してキャリアを形成し、マネジメント職の登用を視野に入れた育成。

ファーマコビジランス職

語学力を活かしてグローバルに活躍

6 - 12 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.
Responsibilities: グローバルPV企画・管理業務
海外子会社（特にアジア地域）のPV業務の管理
オーバーサイト
海外子会社PV担当者と連携し、グローバル基準に準拠したローカルでのPV systemの維持・管理
海外子会社のPV組織立ち上げ
ガバナンス管理

PVにおける品質管理&査察・監査対応

年間休日125日／ワークライフバランス◎／福利厚生充実

6.5 - 12 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: We are a leading biotechnology company focusing on cutting-edge technologies. Our key areas of focus include cancer, kidney disease, and immune disorders. In the field of antibody medicine, we are committed to developing innovative new drugs by combining technologies such as the "Potelligent technology" (which enhances antibody activity by 100 times) and "Human Antibody-Producing Mouse." We are dedicated to establishing a global research and development framework to provide medicines to a large number of patients.
Responsibilities: ■業務内容：
PV活動に関するProcess Complianceや、Audit Inspection Readiness等を担当するグループにおいて、以下の活動の一部をリードして頂きます。
PV部門に関するGlobal/Local手順書の管理及び教育訓練の計画実施
PV活動に関する国内・国外の査察・監査の総合対応
Deviationや査察・監査・自己点検による指摘からのCAPA管理
提携会社、ベンダーとのPV契約及び維持管理、コンプライアンスモニタリング
Regulatory Inteligence

■業務の魅力：
PV業務のグローバル化を進めているため、日々Global HeadやGlobal Leaderと密に協力しあい、変革に取り組むことができる環境です。
Local・Global両方の業務にチャレンジでき、より広い視野を持って業務に取り組むことが可能です。

PV（入力）

PV業務のご経験をお持ちの方必見です

5.5 - 7.62 million yen Osaka Pharmaceutical Pharmacovigilance

Company overview: Our client is one of the most well-established European-based international pharmaceutical companies in Japan.
Responsibilities: 有害事象および関連するすべての症例情報を迅速かつ正確に特定、解釈、抽出する。
多様なソース文書から対応する症例情報を抽出する。
抽出した情報を、重篤および非重篤なAE/ADR症例報告のグローバルデータベースに入力する。AE/ADR症例報告
ソース文書に含まれる製品技術クレームなどの情報を特定する。現地関連会社でさらに処理する必要がある情報を特定し、それに従って転送する。
グローバル規制および SOP で規定されている社内データ入力基準および特定の期限を遵守する。規定およびSOPを遵守する。
受信した報告情報に関して、重要なギャップのない包括的な医療症例のナラティブを作成し、レビューする。
報告された情報に関する包括的な医療症例のナラティブを作成し、レビューする。規制ガイドラインに従って、商品名がINN（国際非プロプライエタリ医薬品）に正しく翻訳されていることを確認する。
INN（国際非専有名称）に正しく翻訳されていることを確認する。受領した重篤な有害事象および非重篤な有害事象、その他の症例情報をMedDRAの用語を用いて正確にコーディングする。
MedDRA 用語を用いた症例情報の正確なコーディングを行う。

ファーマコビジランス職（安全対策）

安全対策業務経験（3年以上）をお持ちの方必見です。

6 - 12 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.
Responsibilities: 治験の安全性モニタリング（安全性管理）業務
申請資料（安全性パート：RMP案、添付文書案）作成
レビュー
市販後安全対策（RMP実施）の推進、安全性情報管理に係る各種ドキュメント作成
治験中、申請中及び市販後の安全性に係る照会事項への対応
安全対策に係る案件に関するグローバル関係者（社内外）との協業

Pharmacovigilance Associate

PV Associate position in Tokyo based maker

5 - 8 million yen Tokyo Pharmaceutical Pharmacovigilance

Company overview: Our client is an international pharmaceutical company.
Responsibilities: 市販薬ならびに治験薬の国内及び外国における有害事象情報を収集、評価、検討し、PMDAならびにGlobal へ報告
市販薬ならびに治験薬の適正使用に関する安全性情報を医薬関係者等へ伝達する資料の作成
GVP省令ならびにGCP省令で求められているRMP、安全性定期報告等その他安全性業務に関する法規制の要求事項についての対応
GVP業務委託先製薬企業と連携の上、ファーマコビジランス業務が適切に行われるよう調整
GVP業務委託業者(CRO)の業務遂行状況を管理し、指導
Global PVならびに海外の規制情報の要求事項を理解し、ファーマコビジランス業務を遂行
経験の浅いメンバーを日常的にサポートおよび指導を行い、メンバーの育成に貢献
既存の業務プロセスの改善を率先して実行

PMS

市販後調査・製造販売後調査経験をお持ちの方必見です。

7 - 10 million yen Chiba Pharmaceutical Quality Assurance / Quality Control

Company overview: Our client is a leading force in the global diagnostics industry, advancing healthcare through innovative diagnostic solutions. The Japan branch, based in Tokyo, employs approximately 500 professionals and supports a wide range of diagnostic products and services, including clinical chemistry, immunoassays, and molecular diagnostics.

Globally, the company operates in over 100 countries with more than 80,000 employees across various facilities and research and development centers. The firm\'s dedication to improving patient outcomes and advancing medical science drives its operations and ensures high-quality diagnostic solutions are available worldwide.
Responsibilities: 市販後調査の業務をお任せいたします。報告に使用する関連情報の収集
ドキュメントの作成
完成後の内容の妥当性確認、関連部署との内容整合、専門家の意見確認など

製造プロセス開発

医薬品メーカー、製薬会社等におけるプロセス開発経験のご経験をお持ちの方必見です

5.2 - 10 million yen Shizuoka Pharmaceutical Research & Development

Company overview: We specialize in the development and manufacture of flavors and fragrances and are active in a wide range of areas including food and beverage, household and personal care products. We have a global presence, particularly in Asia, and use proprietary asymmetric synthesis technology to provide high-quality, near-natural aroma ingredients. With offices, manufacturing facilities, and R&D centers around the world, the company develops products that meet local needs and contribute to cultural and social progress.
Responsibilities: プロセス設計、スケールアップ検討、設備選定、設備設計、安定性試験、リスクアセスメントの実施
  分析法開発（試験法設定、分析法バリデーション、分析法技術移転）
  生産におけるトラブル・変更に対する技術支援
  お取引先との技術的な協議・提案
  実験メンバーへの実験の指示、指導、アドバイスを行いながら、案件の推進とメンバーの育成

品質保証（製造管理／品質管理の維持・改善）

医薬品や医療機器の品質保証部門での業務経験がある方必見です

7 - 8.5 million yen Shizuoka Pharmaceutical Quality Assurance / Quality Control

Company overview: We are a leading Japanese manufacturer and distributor of medical devices and related products. We have a particularly strong reputation in the field of medical devices, such as catheters and artificial heart-lung machines, and we are expanding our business widely both domestically and internationally. We are also expanding into the fields of pharmaceuticals and blood systems, providing comprehensive medical solutions. We focus on innovation and quality control, and develop our products with patient safety and healthcare professionals\' convenience in mind. We aim to contribute to the development of healthcare from a global perspective and are actively involved in the realization of a sustainable society.
Responsibilities: 各製品ごとに小規模なチームが組まれています。まず製品についての知識を学ぶことから始めますが、チームメンバーのほとんどが同様の経験からスタートしており、お互いに気軽に相談しながら業務を進めている環境です。品質情報の解析、報告書の作成、営業チームやユーザーへの報告など
クレームや逸脱の低減を目指した改善業務
開発文書の審査業務

Jobs list of Pharmaceutical

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