IQVIA Services/ Pharmacovigilance/ Operations Specialist 1(Case Processor) - (1724552) in Tokyo, JP at IQVIA™

Date Posted: 5/11/2018

Job Snapshot

Job Description

Join us on our exciting journey!

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

* 医薬品の臨床試験に関するCase processingを担当いただきます。

* 具体的には、有害事象に関する情報の受領、内容確認、データベースへの登録、症例経過の説明文(日本語、英語)の作成、PMDAへの不具合報告要否の一次評価、不具合報告書の作成、QCチェック、顧客との連携などの一連のプロセス、あるいはその一部の業務をプロジェクト別にお任せします。

* 医薬品の治験以外にも、製造販売後のプロジェクト、医療機器のプロジェクトに携わることもあります。



* Receive, triage, review and process Lifecycle Safety data from various sources on time, within budget and quality standards. Perform data entry for tracking and Lifecycle Safety databases, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. Pre-process material for endpoint committee or core laboratory adjudication. Preparation of material for submission of

secondary review.

* Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local Quintiles offices to facilitate expedited reporting. Liaise with systems manager for regulatory tracking requirements and electronic reporting.

* Contribute to individual deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.

Shinagawa Seaside/Osaka Doshomachi

Job Requirements

* 医薬品の安全性業務の実務経験(安全性情報の入力、評価、QC)


* ヘルスサイエンス関連の大学卒および3年以上の安全性関連業務の実務経験者、もしくはそれと同等の教育、トレーニング、経験の組み合わせ。

* 安全性業務(症例評価、様式作成)の規制、実務、システムに関する経験と知識。

* 学習意欲。

* 複数のプロジェクトを担当する中で、業務の優先付けを行い、期限厳守を管理する能力。

* 顧客や他部門、チームメンバーとよい関係を築けること。

* Japanese language proficiency (JLPT>N1)

* Any case processing experience in Pharmacovigilance section of CRO/Manufacturer

* 3 years' Pharmacovigilance-related experience with bachelor or above in health science

* Knowledge of regulation, operation, system for Pharmacovigilance

* Motivation to learn

* Prioritization, time line management

* Teamwork

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.

Job ID: 1724552