MDR/Vigilance Specialist(QA @ Tokyo)

Posted 6 Days Ago
Be an Early Applicant
Tokyo, JPN
In-Office
Junior
Healthtech
The Role
Monitor company drug and medical device surveillance programs, prepare and maintain MDR and ADE reports, review and analyze clinical databases to extract and integrate ADE data, ensure unified safety databases and high-quality safety summaries, and act as liaison with internal and external collaborators to develop regulatory reporting programs and processes.
Summary Generated by Built In

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

職責には、以下に加えて他の任務が追加されることがあります。摂取、プロトコール開発、評価、処理、有害事象報告書のフォローアップを含む会社の薬物や医療機器監視プログラムをモニターし、法的責任の解決や政府規制の準拠に参加する。 規制機関の要求に従い、Medical Device Reports(医療機器レポーティングMDR)、薬物有害事象(ADE)データや有害反応データなどの報告書を作成し正確に維持する。 ADEデータの抽出と統合について臨床データベースのレビューと分析を行い、ADE標準化と内部化の狙いと目的に沿って統一されたデータベースが作成されており、安全性概要が正確で高品質であることを確認する。 規制報告要件を満たすプログラムとプロセスを開発するために社内と社外の協力者の窓口を務める。

メドトロニックスペシャリスト キャリアストリーム:  通常、専門分野または専門分野で責任を持つ個々の貢献者。割り当てられたプロジェクトを提供および/または管理し、他の利害関係者と協力して望ましい結果を達成します。 同僚のメンターとして行動したり、他の下位レベルの専門家の仕事を指示したりする場合があります。 ほとんどの時間は、設計から実装まで、プロジェクトの提供と監督に費やされ、通常は高度な教育を通じて習得した専門知識とスキルを使用して、ポリシーを順守します。

差別化要因

自立性: 定評がある生産的な社員です。 大きなまたは適度に複雑な担当業務やプロジェクトにおいては、一般的な監督下で独立的に職務を遂行します

組織への影響: プロジェクトや課題の目的を達成するために、自身の職務領域の目的を設定します。 プロジェクトのマイルストーンを完了するために貢献します。 職務枠を超えた課題に関与することがあります。

イノベーションと複雑さ: 直面する問題や課題は一般的なもので、幅広い問題やその他の職務領域を理解することが必要になる場合がありますが、通常は複雑なものではありません。 システムやプロセスに調整を加えたり、拡張方法を推奨するなどの行動を取り、問題解決や職務領域の効率化を図ります。

コミュニケーションと影響: 主に社内窓口と頻繁にコミュニケーションを取ります。 外部との関与はそれほど複雑ではなく、または問題解決のためです。 他の人に連絡を取り、情報、状況、ニーズ、問題点を共有して、情報提供、見解の取得、意思決定の支援を行います。

リーダーシップと人材管理: ジュニアな担当者やサポートキャリアストリームの社員にガイダンスやサポートを提供することがあります。

必要な知識と経験: 通常、高等教育と経験から得た、職務領域に関する実践的知識を持ち、能力を実証することが必要になります。 バカロレアの学位(または米国外で取得した学位の場合は、8 C.F.R. § 214.2(h)(4)(iii)(A)の要件を満たし、2年以上の関連経験、または0年の経験を持つ上級学位が必要です。


Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 



Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 



This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here  
 

Skills Required

  • Bachelor's degree (or foreign equivalent meeting 8 C.F.R. §214.2(h)(4)(iii)(A) requirements) plus 2+ years related experience, or advanced degree with 0 years experience
  • Experience with Medical Device Reports (MDR) and adverse drug event (ADE) reporting
  • Experience reviewing and analyzing clinical databases and extracting ADE data
  • Experience developing regulatory reporting programs and processes and working with internal and external stakeholders
  • Ability to ensure accuracy and quality of safety summaries and maintenance of unified safety databases

Medtronic Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Medtronic and has not been reviewed or approved by Medtronic.

  • Parental & Family Support Paid leave for birthing and non-birthing parents is positioned as notably generous, with additional Family Care Leave available for a range of caregiving needs. Fertility, adoption, donor, and surrogacy support adds depth for different paths to family-building.
  • Retirement Support A 401(k) match and an employee stock purchase plan are presented as meaningful long-term savings tools. Scholarship and tuition programs further reinforce financial security beyond salary.
  • Healthcare Strength Medical, dental, and vision coverage is consistently described as a strong part of the total rewards package. Mental health resources, critical illness coverage, and wellness supports broaden the overall health offering.

Medtronic Insights

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The Company
HQ: Minneapolis, MN
80,303 Employees
Year Founded: 1949

What We Do

Medtronic is a global healthcare solutions company operating in approximately 160 countries. We are committed to improving lives through our medical technologies, services, and solutions. Since our beginning, 60 years ago, our Mission has remained the same: to alleviate pain, restore health, and extend life for people around the world. The Mission is our ethical framework and inspirational goal guiding our day-to-day work. It reminds us that our efforts are transforming millions of lives each year. To meet the needs of patients and healthcare professionals around the globe, we operate from more than 370 locations in approximately 160 countries.

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