仕事内容Responsibilities: Project Related Medical/Safety Management:
●Minimize potential risk to this company and clients by managing medical aspects of contracted tasks. This includes, but is not limited to, medical monitoring of all safety variables (AE, laboratory abnormalities, changes in patient medical status as well as inclusion/exclusion criteria, evaluation prescribed concomitant medication for protocol restrictions and unblinding requests). Scope of work also includes discussion internally with medical monitors in Japan, APAC and global and project team colleagues internally, as well as with principal investigators and clients of all medical issues during the course of a study by proper medical judgment, interpretation and decision.
●Medical review of serious adverse events: Ensure tasks delegated to medical monitors are properly executed. Adhere to applicable regulations and ICH guidance regarding clinical trials, regulatory documents, and safety issues. Adhere to client SOPs/directives and project specific WPDs for assigned projects. Adhere to this company’s corporate policies and SOPs/WPDs.
●Present this company standard medical processes to clients at business development meetings, investigator meetings, and communicate with various medical communities to explore and expand this company business.
●Provide medical consultation to team members and help manage protocol related medical questions. Communicate clearly with project team members and clients, maintaining open communication to ensure all procedures are followed appropriately. Provide therapeutic training and protocol training on assigned studies, as requested.
●Perform listing reviews as specified in the client contract and data validation manual, including review of coding listings and/or full safety listings as well as use of Patient Profiles and other tools to assess for potential safety signal. This position will be assigned to APAC components of global or regional studies. Including but not limited to global/regional studies with Japan component.
●This person will also take care of a major responsibility of ICCC review, therapeutic area training to clinical team in this company-SNBL, supporting business development in this company-SNBL, and clients requests including F2F visits to investigators, KOLs and sites in Japan.
※在宅勤務を想定しております。
経験・資格Qualification requirement
●Academic Qualification: -MD degree
●Required Knowledge and skill:
- A certified license of a medical doctor.
- Experience in hospital settings , with a specialty of neurology, oncology, or internal medicine are all welcome.
-Be able to work both in a Japan organization and a regional/global environment.
-Experience in regulatory authority or pharma company would be a plus, but not a must.
●Language: Both Japanese and English proficiency is required.
勤務地
年収
Recruiting No.
社名
事業内容
多くの人が待ち望み、誰も作れなかった新薬を高度な技術で生産し、世界市場に届けます。
医師が安心して意見交換できる会員制サイト『MedPeer』。臨床の「集合知」が新しい価値を生み、ビジネス拡大中です。
「ODMメーカー」として、業界の中で独自の事業展開をしていこうとしています。
真摯で熱い気持ちを持ったメンバーが揃っている会社です
相手と意思疎通を図る、何かしらのツールを持っていて欲しい
