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JP Product Safety Program Manager (Pharmaceutical and Medical device) 薬機法関連製品安全マネージャー

JP Product Safety Program Manager (Pharmaceutical and Medical device) 薬機法関連製品安全マネージャー

Job ID 
643001
勤務地 
JP-13-Meguro
掲載日 
2018-03-27
Company 
Amazon Japan G.K.
Recruiting Team 
..

Job Description

We are looking for talented Product Safety Risk Manager to support our rapidly growing and evolving Retail and Operations businesses.
The Pharmaceutical and Medical Device Safety & Compliance manager (PMD-SC manager) is responsible for developing and implementing guidelines and proactively ensuring Amazon's PMD Safety and the regional/local regulations. The person will work directly with Amazon Operations, Retail, Legal, Customer Service, Tech and a variety of internal businesses to drive PMD-SC in Japan. Actively seek corporation with authorities not only internal but also the external who has strength of risk assessment of PMD & cosmetics to do proactive review and check the test result for some high-risk products to support business expansion. The role must ensure all products in JP Market place meet Amazon's Product Attribute Policy, ensuring safety and compliance is embedded in end-to-end processes. The role is responsible for understanding Amazon's product attribute policy as well as the legal environment that applies to the product Amazon offers for sale. Assists in ensuring that Amazon is legally permitted to sell the products that ship to all customers. The PMD-SC manager plays an important role in safety and risk management, and is a key player in Amazon JP Product Compliance team.
Such a critical role requires the responsibility for independent initiative and ability to drive across JP and linking into all Global Product Safety initiatives and strategies.
アマゾンの製品安全部では急速に成長するビジネスをサポートする製品安全及びコンプライアンスマネジャー(薬機法関連)を求めています。  その職責はアマゾンが国や都道府県の各種法令に適法に、かつ顧客の安全に配慮しながら医薬品、医療機器関連のビジネスを続けていく仕組みを改善し強化し現実化していくことです。 その為に、社内の法務、カスタマーサービス、技術改善部など多くの部署と共同で作業をしていきます。 医薬品や化粧品について知見を持つ社内外、あるいは関係当局とも必要に応じて協議し、あるいは特定の商品のテスト結果などを評価しビジネスの成長をサポートします。 同時に、アマゾンの製品安全と法令順守にかかわる商品ポリシーや作業状態が販売される製品を消費者の手元に届けるまで適切に維持されていることを担保します。 アマゾンが適法に薬機法関連製品を受け入れし、保管し、出荷販売することを適切に維持します。 同時に医療機器とそれに類する製品の安全性の評価を必要に応じて行います。 この職責は責任感と必要に応じて国内外の同僚をけん引していく指導力も望まれます。

Tasks/ Responsibilities:
· Focus on Amazon’s operations for both supply and customer. The primary goal is to ensure regulatory requirements met.
· Progress the optimization of PMD handling of Fulfillment Center processes and enhance competitive advantage and the customer experience.
· Collaboratively work with pharmacist manager / Pharmaceutical Legal counsel and establish a scheme to ensure product safety and compliance at JP Amazon market place for the PMD are primary.
· Lead efforts to ensure regulatory and operational compliance inspection of all incoming new products of consumer / professional goods.
· Assess the risk of PMD related consumer goods products proactively to protect customers.
· Drive and document Product Safety & compliance issues of PMD goods within the company based on customer complaints/customer reviews and customer service follow-ups.
· Design, implement, and maintain PMD safety & compliance specific processes that interface with operations and carriers such as classification databases, restriction databases.
· As the volume, diversity of products and partnerships grow, the PMD Safety Risk manager must be able to leverage resources and work effectively across functions.
· Based in Tokyo Meguro.
- アマゾンの出荷倉庫(FC)を主とするサプライチェーン運営と顧客へ提供する製品が適法である状態を維持する。
- 当社扱いの医薬品医療機器の適性化、合理化と顧客満足度の向上。
- 法務部や筆頭薬剤師、FC担当者と共同で医薬品医療機器の製品安全と法令順守を確実にする。
- 新規導入医療機器に対して適切な評価を行う。
- 医薬品医療機器に苦情が発生した際の調査分析を実施あるいは指揮する。
- 薬機法にかかわる製品を適切に管理するためのデータベースとその維持方法の確立
- 薬機法関連製品に限らず自らの知見を以って他のチームへの協力を行う。
- 東京都目黒区勤務


Basic Qualifications

Experience/skills:
· Bachelor’s Degree, the best preferable experience is registration of medical devices. The experience of registration of Medicines is also preferable.
· Be well aware of JP Pharmaceutical and Medical Device Affairs Law.
· Technical Expertise, creative approach to system and process solutions; advanced.
· Computer literacy (Access, Excel, PowerPoint, Outlook, Word); Data-warehouse tables.
- 大学卒以上 メーカーとして医薬品、医療機器の申請業務の経験。 メーカーあるいは流通業として医薬品、医療機器の業の申請と免許、登録の維持の経験。
- 薬事法あるいは薬機法の下での勤務経験。
- 懸念や問題を仕組みやプロセスを作ることで解決した経験。
- PCスキル、(マイクロソフトオフィス、Outlook、Datawarehoseなど)

Interpersonal skills:
· Communication: Strong written and oral communication skills in both English and Japanese. Writes, speaks and presents information effectively, clearly, and with brevity.
· Develops and maintains good working relationships with others. Treats others with respect. Builds trust and rapport. Practices and promotes involvement and cooperation.
· Results Orientated: Must have a strong drive for results and the ability to thrive in ambiguity, enjoy learning vast avenues of business functions and vendor/ manufacturer/ customer relations, and the creative use of scare resources.
- 日本語(母語レベル)と英語(ビジネスレベル)の読み書き会話のコミュニケーション能力を有すること。
- チームワーカーであること。 相互尊重の姿勢を持っていること。 関与し、協力することを実践できる。
- 結果を出す。 新しいことを学ぶことに喜びを持ち多くの社内外の関係者と協力し成果を上げる。



Preferred Qualifications

Not all but any
· 3+ years Quality Control, Quality Assurance and/or Quality Management System experience at pharmaceutical, medical device or health science companies.
· 5+ years Product Safety/Compliance, Regulatory Legal or related environment.
· A mix of compliance and program management experience.
· 3+ years Non-Japanese capital company (Gaishi-kei) experience.
· Specific knowledge and/or experience with JP and international regulations of Consumer product compliance/safety regulations, drug, cosmetic regulations and environmental regulations.
· National license of Medical Doctor, Pharmacist or Veterinary will be valued.
Amazon is an Equal Opportunity-Affirmative Action Employer - Minority / Female / Disability / Veteran / Gender Identity / Sexual Orientation
- 医薬品、医療機器のメーカー、輸入業、販売業あるいはヘルスサイエンス系で3年以上の品質保証、品質管理、QMSあるいは倉庫、保管場所に対する薬機法上の管理経験。 
- 5年以上の御製品安全、製品法規、あるいはそれに類する経験
- 3年以上の外資系勤務経験
- 化粧品、医薬品、日用品にかかわる内外の製品安全や環境規制についての知識
- 薬剤師、医師、獣医師の資格があれば尚可だが必須ではない。