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IQVIA Pharmacovigilance/ Pharmacovigilance Specialist/ IQVIA Services in Osaka, Japan

■担当業務

  • 治験または市販後に関する、医薬品または医療機器の安全性情報管理プロジェクトのメンバーとして以下のCase processingタスクを担当する

  • 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・入力およびQC

  • 症例経過の説明文(日本語、英語)の作成およびQC

  • PMDAへの不具合報告要否の一次評価、および評価内容のQC

  • 不具合報告書の作成およびQC

  • 顧客へのエスカレーション、調整など

■勤務地

Flexible Style Work適用(在宅ベース)

必要によりオフィス(品川シーサイド/新大阪)に出勤

■候補者の要件

■必須

  • 安全性情報ケースプロセッシング(入力、トリアージ、評価、QC)経験が1年以上有ること(入力のみでも選考致します。)

  • ビジネスレベルの日本語能力

  • 辞書を使用して簡単な英文の読解、簡単な文章作成が出来ること

  • 高専・短大・専門学校卒業以上の学歴

■尚可

  • 国内市販後症例の入力/入力データのQC業務1年以上(必須)を含む、PV業務3年以上の経験。

  • 医薬品安全性情報業務において、何らかのリーダーシップをとった経験(新人・後輩へのOJT、SOP見直し、システム更新、進捗・品質の管理など)

  • 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。

  • TOEIC600点以上、または、左記相当の英語力

  • 医療系の学歴(医学・薬学・臨床検査・看護など)

■Role & Responsibility

  • As a member of clinical or post-marketing PV project of drug or medical device, handle one or multiple case processing tasks below depends on his/her experience.

  • Reception, triage, book in, data entry and QC

  • Descripting Narratives (English & Japanese) and QC

  • Assessment and QC to assessment

  • Generating reports to PMDA and its QC

  • Escalation and coordination with customers

■Workplace

Flexible Style Work (Home Based)

Commute to office (Shinagawa Seaside (Tokyo) / Shin-Osaka (Osaka) as ne

■Requirements

■Essential

  • Over 1-year hands-on experience in pharmacovigilance case processing (data entry, triage, evaluation, QC, submission). Open to candidates with only data entry experience.

  • Japanese language proficiency of business level

  • Ability to read and write short sentences using English dictionaries

  • Associate degree or higher

■Nice to have

  • Over 3-year hands-on PV experience including 1-year in pharmacovigilance Quality Check/Control for entered data.

  • Any leadership experience in pharmacovigilance. (e.g. OJT, SOP renewal, system update, managing timeline and quality)

  • English proficiency: TOEIC 600 or equivalent

  • Ability to prioritize, timeline management

  • Ability to make good relationship with stakeholders, leadership

  • Medical background (Medicine, Pharmacy, Medical Technology, Nursing, etc.)

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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