Pharmacovigilance System • Implement and maintain a pharmacovigilance system for the UCB products authorized in the territory and ensure compliance with applicable regulatory and company requirements; • Work in close collaboration with corporate Patient Safety teams to ensure
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
安全管理責任者 - Safety Control Manager Who we are: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high
Primary Purpose / Regulatory Responsibilities: Collaborate with the Process Management Team members and the Product Management Team members to ensure Safety communication and product stewardship • Ensure Pharmacovigilance systems, operations and procedures are in place within the
Company Description Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes. Our mission is to be at the forefront of minimally invasive cancer and
Japan Study Managerは、日本国内において治験の管理・監督を担い、CROや治験実施医療機関と連携しながら、治験参加者の安全と福祉、治験の品質を確保し、治験の計画通りの実施をリードします。グローバル・ローカル双方と連携し、課題解決や進捗管理も担当します。 JOB SUMMARY & RESPONSIBILITIES Responsible for in country study/site management and clinical/scientific oversight activities of assigned clinical trials to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices
企業概要 We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North
Job Overview: Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and
SAS II Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate
CRA II Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle
JOB DESCRIPTION: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you
Primary Purpose / Regulatory Responsibilities: The primary purpose of a Project Manager (PM) is to ensure and elevate the level of country operations to realize patient value by transforming company’s strategy into project delivery in Japan. A
Roles providing expertise on scientific topics regarding relevant disease areas and Company assets to ensure their safe and appropriate use by patients. Acts as a field-based expert, building relationships with External Experts as trusted scientific partners. Exchanges
Roles providing expertise on scientific topics regarding relevant disease areas and Company assets to ensure their safe and appropriate use by patients. Acts as an office-based scientific expert, collaborating with internal and external stakeholders. Translates scientific data
■KEY TASKS Collect medical/scientific information regarding company products and respond promptly to inquiries and requests from internal and external stakeholders. Provide medical information on the products and act as the local main point of contact for
Primary Purpose: Provides Japanese Labelling & Artwork Regulatory expertise across a Therapeutic business unit. Delivers strategic and operational regulatory input and guidance to the cross functional teams. MAJOR RESPONSIBILITIES • Creation, update and maintenance of the
The Medical Science Liaison (MSL) is a field-facing role whose main objectives are to: exhibit a high degree of scientific and clinical knowledge, i.e. a robust knowledge of diseases, vaccinology, product development, clinical trials exhibit a
Department: GQP Compliance Group Report to: Head of Quality Japan General This role is to serve as an expert in the key quality management system for Japan subsidiary with regards to GxP requirements as well as
QA Expert This role is to serve as an expert in the key quality management system for Japan subsidiary with regards to GxP requirements as well as Japanese Pharmaceutical Laws. Support the Quality Manager with the