医師／関西の求人・転職情報

■Responsibilities: Project Related Medical/Safety Management:

◇Minimize potential risk to PPD 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 PPD’s corporate policies and SOPs/WPDs.

◇Present PPD standard medical processes to clients at business development meetings, investigator meetings, and communicate with various medical communities to explore and expand PPD 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 PPD-SNBL, supporting business development in PPD-SNBL, and clients requests including F2F visits to investigators, KOLs and sites in Japan.

治験の設計と実施に当たって、医学的、科学的専門知識を提供する。
• 医学的および科学的専門知識を背景とした臨床的判断に基づき、開発プログラムの開発計画に戦略的提言を行う。
• 安全管理部と協力して、有害事象の分析と評価を行う。
• 治験におけるメディカルモニタリング。
• 申請のための文書の準備の支援とレビュー。
• 規制当局との会議への出席。
• CROマネジメントにおける医学的、科学的観点からの支援。
• プロトコル、クリニカルスタディレポートの作成支援。
• 社内外の科学専門家との関係構築/維持。
• 開発本部メンバーへの基礎的医学知識の共有と教育
• 導入品評価のサポート
• 社内の意思決定機関に対する医学的、科学的な情報の提供

• Providing scientific and medical expertise to the design and implementation of clinical studies
• Providing strategic and operational guidance to teams, based on medical and scientific expertise and sound clinical judgment.
• Supporting product development and research programs
• Medical monitoring for clinical studies.
• Assisting in the preparation and review of documents for regulatory reports.
• Present clinical study outcomes and other critical data at various meetings which include but not limited to the PMDA and other regulatory authorities, academic conferences and medical congresses.
• Providing medical leadership and scientific guidance to CROs and Regulatory Affairs.
• Co-authoring protocols, clinical study reports and CTD Sections.
• Developing/maintaining strong relationships with internal and external scientific experts to lead the company’s interests from a medical perspective.
• Promoting and participating in a culture of learning and continuous education, including remaining current through literature review, attendance at medical/scientific meetings, etc.
• Providing coaching and subject matter expertise to team members and colleagues.
• Supporting in-licensing efforts by providing medical expertise and planning assistance
• Evaluating pipeline products to give input to decisions based on solid assessment of potential for development and resource needs.

大阪エリアを管理する専属産業医として従事いただきます。主な業務は以下となります。

・他拠点の産業医との連携、産業保健活動全般の方針策定、産業保健スタッフの労務管理
・健康診断の実施、その結果に基づく労働者の健康保持するための措置
・1か月当たり80時間超の長時間労働者に対する面接、指導等、事後措置
・ストレスチェックにおける高ストレス者への面接指導、事後措置
・休復職支援、面接、指導等　
・作業環境の維持管理（月１回の職場巡視、安全衛生委員会への参加）、衛生教育等
・労働者の健康障害の原因の調査、再発防止のための措置
・労働者の健康維持、予防に関する教育等　など