Drug Safety Specialist / 安全性情報チームリーダー

■職務内容

薬事法や安全性に関する規制、顧客及び社内の標準操作手順(SOP)を遵守し、国内外の医薬品、医療機器に関する有害事象、副作用情報、不具合情報の収集、評価、報告を行う業務です 。

具体的には下記の業務です

・国内における治験／製造販売後安全性情報、文献学会情報のトリアージ及び一次評価

・CIOMSや文献学会情報等による海外（英語）安全性情報の一次評価、和訳

・MRへの再調査指示業務

・医薬品医療機器総合機構への(医薬品)副作用、研究報告、措置報告、不具合報告書（案）の作成

・各種の期限管理

・顧客との手順やルールの調整、窓口業務

・その他、クライアントの指示命令事項

・手順やルールの習熟を背景とした品質向上のための具体案の作成やトレーニングの実施

・チーム・リードやチーム・ビルディングに関するサポート

Basic Function: Responsible for capturing and assessing single adverse event reports associated with client products on the client’s Drug Safety database, in accordance with international and local regulatory requirements

Principal Functional Responsibilities:

• Determining the category of information received i.e. whether it is a Medical Inquiry, Product Quality Complaint (PQC), an adverse event (AE) associated with a PQC, or an AE alone, and handling it accordingly per the relevant SOPs and guidelines

• Creating/generating AE/Product Complaint forms in the Product Complaint System

• Keeping track of the Product Quality Complaints

• Performing clear and accurate data capture of cases (including serious and non-serious cases from spontaneous and clinical trials origin, literature and E2B cases, as applicable) and appropriate medical assessment (including company causality and assessment of expectedness) of cases in accordance with client conventions/guidelines and Standard Operating Procedures

• Reviewing ancillary documentation accompanying the reports and identifying the relevant information for processing and electronic capture in the applicable database

• Maintaining an excellent knowledge of case processing conventions and guidelines, client’s procedures and international drug safety regulations

• Maintaining a good working knowledge of the AE safety profile of assigned products and labeling documents

• Ensuring MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”, where applicable

• Interacting with internal or external contacts to resolve issues related to the processing of cases and PQCs

• Responding to clients/customers in a timely manner

• Performing triage of literature abstracts and/or full articles for validity, if required

• Performing single case creation/initiation in the safety database, if required

• Mentoring new recruits in the team, if required

• Identifying areas of concern within the team and raising the issues with the Team Lead

• Maintaining an awareness of the performance metrics measured by client and striving to remain within established limits

Note: The above statements describe the general nature and level of work being performed, and are not an exhaustive list of all responsibilities required for the position.Qualifications■必要条件

・医薬品の安全性関連業務を5年以上経験された方

・英語で業務を行いたい方、尚可。

■求める人物像:

・チーム・リードや人員管理のサポート経験をお持ちの方

・良好な人間関係を築けるコミュニケーション能力をお持ちの方。

・クライアントの要求事項を理解したうえで、顧客満足を意識しつつ、取り組むことができる方。

・与えられた仕事や新しい仕事に対して、フレキシブルで真摯な態度で、取り組むことができる方。

Qualifications and Experience:

• Science/Medicine degree: The minimum qualification required would be a University degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.) , or equivalent qualification/work experience

• A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine, which involves patient exposure in hospital based environment, would be an advantage

• Good knowledge of medical terminology

• Fluency in written and spoken English and Japanese

• Computer proficiency, an ability to work with web-based applications, and familiarity with the Windows Operating System and the MS Office suite (Word/Excel/Power Point)

• Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text

• Ability to evaluate data and draw conclusions independently

• Typing and transcription accuracy

• Team player