その他、技術・専門職系(メディカル)
Safety Manager
その他、技術・専門職系(メディカル)

Safety Manager
の転職・求人情報はすでに掲載終了しております。(掲載期間12月21日~1月15日)

※ 掲載時の募集要項はページ下部よりご確認いただけます。
他の方はこんな求人もチェックしています
ミドルの転職では、各専門分野のコンサルタント4723が紹介する181019の転職情報を掲載しています。
希望条件で探す
職種、勤務地、年収などを組み合わせて探すことができます。
掲載時の募集要項掲載期間:2022/12/21 ~ 2023/01/15)
その他、技術・専門職系(メディカル)

Safety Manager

外資系企業 海外展開あり(日系グローバル企業) ベンチャー企業 管理職・マネジャー 海外出張 海外折衝 土日祝休み

募集要項

募集背景
<POSITION OVERVIEW>

The Post-Marketing Safety Controller's responsibilities include PMS, evaluation of safety information, planning and implementing countermeasures to ensure better safety and safety assurance training for other personnel. Responsible for ensuring proper documentation and filing of all product safety information including biologic reports as needed. These documents should be available as preparation for possible inquiry by PMDA.



The Post-Marketing Safety Controller will oversee all activities related to investigating complaint associated with product in Japan under the direction of department management. The Post-Marketing Safety Controller will perform complaint investigations and follow established global regulations for complaint handling.
仕事内容
Anseki
<RESPONSIBILITIES>

MANAGEMENT OF COMPLAINT SYSTEM

* Responsible for Good Vigilance Practice (GVP)
* Manage complaint database and files for all customer complaints in Japan.
* Assist with development and standardization of complaint investigations.
* Ensures procedures are in compliance with appropriate regulatory requirements.

COMPLAINT INVESTIGATION/REPORTABILITY OF ADVERSE EVENTS

* Perform reportability assessments
* Conducts clinical follow ups with customers in Japan as needed.
* Provide reports to health authorities on adverse incident and recalls.
* Maintains log of reportable events
* Overseas all aspect of the complaint investigation from opening to closure
* Reviewing complaint records for accuracy and completeness.
* Monitor safety of products released into the market

PROCESS DEVELOPMENT

* Responsible for process development to ensure compliance with PMDA regulations.
* Develops processes to ensure compliance with SOPs

BIOLOGICAL PRODUCT TRACKING PROCESS

* Enters daily shipping records and delivery records received from distributors into the traceability system

OTHER

* Trains employees in Japan on complaint and adverse event reporting.
* Provide ancillary support in representing the complaint handling process during audits
* Collecting data for post market studies as needed (Travel 5-10%) All other duties and tasks as required and requested by management.

Real is part of the larger SThree K.K group

To find out more about Real, please visit www.realstaffing.com | Real についてもっと詳しく知りたい方はこちらへ→ www.realstaffing.com



Award winner of:

Great Place to Work 2019 | Growth Company of the Year by TALint Recruitment Awards 2019 | Best Healthcare & Life Sciences Recruitment Company of the Year by Recruitment International Awards 2018
応募資格
必須
Anseki
フィットする人物像
<QUALIFICATIONS>

* Bilingual; English and Japanese
* Knowledge of Ordinance #169, ISO 13485 and Japanese PMD Act
* Excellent written skills required due to frequent interaction with practicing ophthalmologists
* Prior experience with complaints management system
* Ability to manage reporting timelines and to train employees on complaint and investigation requirements
* Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities
* At least three years in a post-marketing safety or quality assurance position at a pharmaceutical or medical device company
* Ophthalmology experience preferable.
* Bachelor's degree (preferably life sciences) at a minimum
雇用形態
Permanent
勤務地
Tokyo
年収・給与
JPY10,000,000.00 - JPY12,000,000.00 per annum + competitive

会社概要

社名
非公開
事業内容・会社の特長
<ABOUT THE COMPANY>

Medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness.
30代、40代の転職サイトはミドルの転職に会員登録すると…
  • 1あなたの希望にマッチした「新着求人情報」が届きます。
  • 2仕事が忙しくても、コンサルタントからの「スカウト」を待てます。
  • 3気になるリスト」などの便利な機能を使えるようになります。
転職先がご決定されたみなさまへ
毎月50名様にAmazonギフト券5,000円分をブレゼント!
転職先情報の入力へ
Q.
エージェント(人材紹介会社)を利用して、転職をするメリットは何でしょうか。
A.
一般に公募していない非公開求人情報が得られるほか、キャリアやスキルを査定して最適な転職先を紹介してもらえる、転職を希望する企業がある場合、採用の可能性を判断してもらえます。

実際の転職活動の際にも、紹介先企業の企業の人事方針や経営に関する詳細な情報が事前に得られたり、履歴書や職務経歴書の書き方や、面接でのアドバイスがもらえるなど、有利に転職活動ができるようにサポートをしてもらえます。

また、より良い待遇条件で転職が決まるように条件面での交渉をしてもらえます。
Safety Managerの転職・求人情報 17884042。プロのコンサルタントがサポートする日本最大級のキャリア転職情報サイト。年収800万円以上の高年収、管理職、スペシャリストの求人、非公開求人スカウトも多数。