Job Description 【募集メッセージ】 ファーマコビジランス Safety Risk Management(SRM)は、開発段階から市販後まで一貫して医薬品・ワクチンのリスクマネジメントを担います。 社内外のステークホルダーと協議し、日本におけるリスクマネジメントプランを立案し、実行いただける方を募集します。 【主な業務内容】 開発品安全性業務 申請時電子添文「使用上の注意」、J-RMP(安全性検討事項、安全性監視計画、リスク最小化策)の立案、作成 CTDの関連パート作成、審査対応 製造販売後調査プロトコル作成 最適使用推進ガイドライン(GL) 作成・改訂 ※オンコロジー領域のみ 市販品安全性業務 集積情報等にもとづく安全確保措置の検討 電子添文、J-RMP改訂要否検討及び改訂案作成(PMDA、米国本社及び国内他社等との交渉/相談含む) 情報提供資材の作成・改訂 製造販売後調査のプロトコル改訂 最適使用推進GL改訂 ※オンコロジー領域のみ 安全性定期報告書及び再審査申請資料の安全性パート作成 市販後安全対策全般に関する外部医学専門家とのコミュニケーション、各学会対応 【必須条件】 製薬企業での医薬品・ワクチンに関する実務経験 国内外の規制 (薬機法、GCP、GVP、GPSP等)に関する基礎知識 社内外ステークホルダーの効果的なマネジメント能力 (関係構築、調整、交渉等) ファーマコビジランスを体現できる科学的な観察力、思考力、考察力 英語での業務遂行能力(TOEIC 730点以上あるいはGBCスコア1.6以上) 【望ましい条件】 ファーマコビジランスにおける承認申請、市販後安全対策の業務経験
Company Description Continental develops pioneering technologies and services for sustainable and connected mobility of people and their goods. Founded in 1871, the technology company offers safe, efficient, intelligent and affordable solutions for vehicles, machines, traffic and
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.
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.
Responsibilities include : Supporting identification and collection of competitive technical product information Providing market-specific claims, merchandising information, and Distributor selling points, demos, and practices for current generation benchmark products. Partnering with peers in global R&D to identify
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your
The Trade Desk is a global technology company and the world’s leading independent platform for digital advertising, with nearly 4,000 employees across more than 30 offices. Our technology helps advertisers reach the right audiences across the
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.
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
Welcome to Ingenico Payments happen everywhere. In shops, on busy streets, and across countless digital touchpoints. In many of these everyday moments, Ingenico quietly powers the way customers pay. As a global leader in payment acceptance,
企業概要 About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples
Job Description Position Summary The Consumables & Supplies Product Specialist is a senior technical‑commercial role responsible for driving new business in strategic markets and customers to increase Agilent’s market share and recurring revenue in laboratory supplies, sample
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.
WANT TO REVOLUTIONIZE GOLF? Our mission is to help people enjoy the wonderful game of golf even more by developing tracing technology for TV and gamification to ranges. Our product brings people together and encourages them
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.
For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and
Company Description From August 1 2025, Bosch Home Comfort Group acquired 100% of the Johnson Controls-Hitachi Air Conditioning joint venture, including the 60% stake owned by Johnson Controls International plc and the 40% stake owned by
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
Recruitment Team Manager - Life Sciences - Japan Brand: Proclinical Location: Tokyo Salary: ¥11m (+Commission) Are you an experienced Life Sciences agency recruiter with leadership experience who is looking for a new challenge? Do you want
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring