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  3. Specialist, Pharmacovigilance(Oncology)

Specialist, Pharmacovigilance(Oncology)

450 〜 1100 ten thousand JPY

  • RGF HR Agent
  • Location: Tokyo
  • Japanese level:Fluent │Required length of experience:Uncategorized
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Date:2019/02/08~2019/10/21

Job summary

Job category Professional (Consulting / Finance / Real Estate / Professional Services)/Professional Services (Health Care / Welfare / Education / Instruction)
Industry Health Care/ Other Health Care
Employment type Uncategorized
Position level Other
Number of openings 1
Desired entry time -
Required language skill

English (Conversation)

Japanese (Fluent)

Foreign language competence -
Working hours Others
Welfares / Leave systems
Assistance in visa application -
Number of foreign employees -

Work details

Company Overview
大手外資製薬メーカー/オンコロジー領域へ注力/福利厚生充実

Job Description
オンコロジー領域の医薬品に関する下記業務:
- 開発品安全性業務
- 開発段階からの市販後安全対策の立案
- 申請時添付文書「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の安全性パート作成、審査対応
- 最適使用推進ガイドライン、使用上の注意の解説の作成・改訂
- 市販品安全性に関する集積検討、安全対策の立案
- 安全性シグナルの検出
- 添付文書、J-RMP改訂要否検討及び改訂案作成
- 添付文書、J-RMP改訂に関する、PMDA、本社及び国内他社等との交渉/相談
- その他安全対策の検討、適正使用資材の作成
- 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

その他:
- 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
- 医療従事者からの副作用問い合わせに対する回答作成

The following tasks in Oncology Safety area:
- Conduct safety tasks for Investigational Drugs
- Plan post-marketing safety measures from the development stage
- Prepare "Precautions" in the local labeling and "Safety Concerns, Pharmacovigilance Plans, and Risk Minimization Measures" in the J-RMP for local New Drug Application (J-NDA)
- Prepare safety sections of the Common Technical Document (CTD), and respond to regulatory review
- Prepare and revise "Optimal Clinical Use Guidelines" and "Explanation of Precautions of New Drugs"
- Review aggregate safety information of marketed products and discuss/perform safety measures
- Detect safety signals
- Examine the necessity of revisions of local labeling and J-RMP, and prepare revised documents
- Negotiate/consult with PMDA, HQ, and other business partners on revision of local labeling and J-RMPs
- Discuss other safety measures and prepare materials for proper use
- Prepare safety part of local Periodic Safety Update Report and Reexamination Application dossier

Others:
- Communicate with external medical experts and academic societies on overall post-marketing safety measures
- Respond to inquiries from healthcare professionals on adverse reactions

Requirements
必須:
抗がん剤、オンコロジー領域に関する医学的知識
社内(国内・外)関連部門、規制当局、外部医学専門家と良好な関係を築くことができるコミュニケーションスキル、協働、交渉するスキル
問題の本質をとらえて適切な対策をとれる分析力、解決能力
海外との日常業務ができるレベルの英語力
業務を行うためのITスキル

望ましい資質:
薬機法、GCP、GVP、GPSP、等安全性業務関連の国内外の規制に関する基礎知識
オンコロジー領域の安全性業務経験

Prerequisite:
Basic knowledge about medical science in anti-cancer drugs and Oncology area.
Communication, collaboration, and negotiation skills that can build good relationships with relevant internal departments (in and outside Japan), regulatory agencies, and external medical experts
Ability to analyze and resolve problems, and take appropriate measures by identifying essential problems
English skills to perform daily work with overseas divisions
IT skills to perform daily work

Preferred qualities:
Basic knowledge about domestic and overseas regulations related to safety-related duties, such as the Pharmaceutical Equipment Law, GCP, GVP, GPSP, etc.
Work experience in Oncology safety area

About interview

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Name of person in charge of hiring:

Specialist, Pharmacovigilance(Oncology)

RGF HR Agent

450 〜 1100 ten thousand JPY

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Company overview

RGF HR AgentSpecialist, Pharmacovigilance(Oncology) RGF HR AgentSpecialist, Pharmacovigilance(Oncology)

RGF HR Agent

Human Resources / Education / Consulting / Professional Services /Staffing / Recruiting

RGF (Recruit Global Family) is the overseas corporation of Recruit Holdings Co., Ltd., Japan's largest talent comprehensive service and information service group enterprise, has started for more than 50 years, based on excellent business philosophy and management experience. Transcend national borders, we will discover new opportunities and possibilities worldwide.
RGF HR Agent provides solid support for the hiring activities of companies and the job-hunting activities of applicants as a general HR service company.
We provide not only regular recruitment but also RPO (Recruitment Process Outsourcing), contracts and so on. We deliver comprehensive services that could only be offered by RECRUIT=RGF, which is number one in Japan in the field of talent introduction, temporary staffing and recruitment information advertising. Having thoroughly met the needs of leading companies in Japan, we will also provide our consummate, high-quality services overseas. RECRUIT=RGF, which is number one in Japan, will continue taking on the challenge of becoming number one in the world.

JAPAN: RGF HR Agent Japan (CDS)
Address: 東京都渋谷区広尾1-13-7恵比寿イーストビル2F
TEL (+81)3-6422-4400
Website: http://www.rgf-hragent.asia/en/japan

CHINA: RGF HR Agent (Shanghai)
Address: 上海市淮海中路8号 蘭生大厦9F
TEL (+86) 21 5331 8000
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Suzhou)
Address: 蘇州市工業園区蘇州大道西1号 世紀金融大厦1615室
TEL (+86) 512 6262 3595
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Beijing)
Address: 北京市朝陽区東三環中路39号建外SOHO,A座902室
TEL (+86) 10 5869 0121
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Tianjin)
Address: 天津市和平区南京路189号津汇広場一号楼1106单元
TEL (+86) 22 2331 1169
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Dalian)
Address: 大连市高新技术产业园区黄浦路537号(七贤路)泰德大厦811室
TEL (+86) 411 8445 7095
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Guangzhou)
Address: 广州市天河区林和西路161号 中泰国际广场A塔1309室
TEL (+86) 20 8527 4585
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Shenzhen)
Address: 深圳市罗湖区嘉宾路2018号深华商业大厦2507室
TEL (+86) 755 8237 5208
Website: http://www.rgf-hragent.asia/china

HONGKONG: RGF HR Agent Hong Kong Limited
Address: Unit 2206, 22/F, Wu Chung House, 213 Queen’s Road East, Wan Chai, Hong Kong
TEL (+852) 2537 2557
Website: http://www.rgf-hragent.asia/en/hongkong

VIETNAM: RGF HR Agent Vietnam Co., Ltd.
Address: RM903 Central Plaza 17 Le Duan St., Dist 1 Ho Chi Minh City
TEL (+84) 8 3911 5800
Website: http://www.rgf-hragent.asia/en/vietnam

THAILAND: RGF HR Agent Recruitment (Thailand) Co., Ltd.
Address: 689 BHIRAJ TOWER at EmQuartier, 23rd Floor, Room No. 2304-2306 Sukhumvit Road, North Klongton Sub-District, Vadhana District, Bangkok 10110
TEL (+66)2-021-0333
Website: http://www.rgf-hragent.asia/thailand/

SINGAPORE: RGF HR Agent Singapore Pte. Ltd.
Address: 71 Robinson Road #05-04 Singapore 068895
TEL (+65) 6221 7437
Website: http://www.rgf-hr.com.sg/

INDIA: RGF Select India Private Limited
Address: 704-705-706, 7th Floor, Vatika City Point, MGRoad, Gurgaon 122002
TEL (+91)124 4139711
Website: http://www.rgf-hragent.asia/en/india

INDONESIA: PT. RGF Human Resources Agent Indonesia
Address: Jakarta Office: Graha Pratama, P1F (21F), Jl. M.T.Haryono Kav. 15, Jakarta 12810, Indonesia
TEL (+62) 21 8378 2866
Website: http://www.rgf-hragent.asia/en/indonesia

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