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Merck KGaA, Darmstadt, Germany and its affiliates · Tokyo, Japan

# Pharmacovigilance Scientist, Global Patient Safety Japan_ Biopharma

Tokyo, Japan Full-time Healthcare & Clinical 

Listed on Merck KGaA, Darmstadt, Germany and its affiliates’s official careers site. Posted October 11, 2026. Check that it is still open and apply there.
[Apply on Merck KGaA, Darmstadt, Germany and its affiliates’s careers site →](https://careers.merckgroup.com/global/en/job/MQAMKDGLOBAL302210EXTERNALENGLOBAL/Pharmacovigilance-Scientist-Global-Patient-Safety-Japan-Biopharma)

[OpenNash Jobs](https://jobs.opennash.com/) / [Merck KGaA, Darmstadt, Germany and its affiliates](https://jobs.opennash.com/companies/merck-kgaa-germany/) / Pharmacovigilance Scientist, Global Patient Safety Japan_ Biopharma

## Job description

メルクと一緒に、あなたの力を発揮しよう！ 冒険、限界への挑戦、そして発見に焦がれるあなたへ。あなたの大志を、メルクで羽ばたかせましょう！科学とテクノロジーを駆使したイノベーションに情熱を注ぐメルクのスタッフは世界中で活躍中です。ヘルスケア、生命科学、エレクトロニクスの分野で、メルクのソリューションは人々の暮らしをますます豊かなものにしています。あなたとメルクの力を合わせて、大きな夢を抱きましょう。メルクは、人、顧客、患者、そしてこの地球という惑星が共存する豊かな世界の構築に情熱を注いでいます。このためメルクでは、好奇心にあふれた人材を募集中です。メルクと一緒に、想像を超えた世界を開拓しませんか？ 患者さんのためにひとつになって団結し、生命の誕生、QOLの向上、命をつなぐサポートをすることか、ヘルスケアにおける私たちの目的です。私たちは、腫瘍学、神経学、不妊治療などの疾患領域において、医薬品、インテリジェント装置、革新的技術を開発します。

私たちのチームは、人生のすべてのステージで患者さんを助けるために、情熱と執拗な好奇心を持って6大陸全体で協力して働いています。ヘルスケアチームに入ることは、多様的で包含的、そして柔軟な職場文化の一部となることです。世界中で個人的な能力開発とキャリアアップの素晴らしいチャンスが待ち受けています。 Job Requisition – Pharmacovigilance Scientist, Global Patient Safety Japan Merck Biopharma Japan is seeking an experienced Pharmacovigilance Scientist to join Global Patient Safety (GPS) Japan. This is a highly visible role requiring strong scientific leadership in the assessment, interpretation, and management of safety data for both investigational and marketed products in Japan.

The successful candidate will play a critical role in driving product safety strategies and supporting key regulatory milestones throughout the product lifecycle. The position requires the ability to lead safety evaluation and regulatory response activities for development programs and new drug applications, including preparation of safety components of submission dossiers, support for PMDA interactions, responses to regulatory inquiries, periodic safety reports, risk management plans (RMPs), and re-examination submissions.

The individual will be expected to provide expert medical and scientific judgment on emerging safety issues, benefit-risk assessments, signal detection and management activities, and Japan-specific safety strategies. Working closely with global and local cross-functional teams, the Pharmacovigilance Scientist will contribute to clinical development, regulatory filings, safety governance meetings, and inspection readiness activities.

The role demands the ability to independently analyze complex safety information, communicate recommendations to senior stakeholders, and influence safety-related decision-making in a fast-paced global environment.

### Qualifications

MD, Pharmacist, PhD, or other advanced life science degree Native-level Japanese and fluent English communication skills Significant pharmacovigilance experience, preferably across both clinical development and post-marketing settings
- Strong knowledge of Japanese and global pharmacovigilance regulations, signal management, benefit-risk assessment, and safety reporting
- Demonstrated experience working within global cross-functional teams and managing complex regulatory safety activities This role is ideal for a safety professional who can provide strategic leadership in product safety and successfully guide regulatory safety activities supporting critical development and submission objectives in Japan.

### 私たちが提供するもの

私たちは、さまざまな背景、視点、人生経験を持つ好奇心旺盛な人々で構成されるグループです。この多様性が卓越性と革新を促進し、科学と技術のリーダーシップを強化すると信じています。私たちは、すべての人が自分のペースで成長し発展するためのアクセスと機会を創出することにコミットしています。何百万もの人々に影響を与え、誰もが人類の進歩を支持できるようにする包括性と帰属感のある文化を築くために私たちに参加してください！ 今すぐ応募して、発見を促し、人類の発展を高めることに専念するチームの一員になりましょう！

## At a glance
- Posted by the employer: Oct 11, 2026
- First seen by OpenNash: Oct 19, 2026
- Last checked: Oct 19, 2026
- Listed for: 8 days
- Location: Tokyo, Japan
- Employment type: Full-time[Apply on Merck KGaA, Darmstadt, Germany and its affiliates’s careers site →](https://careers.merckgroup.com/global/en/job/MQAMKDGLOBAL302210EXTERNALENGLOBAL/Pharmacovigilance-Scientist-Global-Patient-Safety-Japan-Biopharma)

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