Quality Specialist In Clinical Safety
hace 2 meses
.At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.The purpose of the role is to support the development and implementation of quality systems strategy and activities to support International Business Unit (IBU) goals and objectives for assigned countries or regions.In support of this mission, the purpose of this role within an Affiliate/Region is to act as a quality consultant and leader in integrating the quality requirements into the business processes. The role will implement the quality plan and ensure consistency between the global requirements and local requirements. This includes the implementation of Safety and Efficacy quality system and assuring that this system is aligned with appropriate quality and regulatory requirements. Provide updates on internal/external GxP trends and changes through the country/regional affiliate leadership team(s). Acting as a contact person regarding quality and business process compliance concerns between affiliates and global.Responsibilities Implement and Manage Quality SystemsContribute to the development and review of country/region specific quality system documents to ensure requirements and accountabilities are represented.Approve regional and/or local required tools, resources, forms, templates.Assist in interpreting relevant regulations and guidelines and act as a contact person for global and affiliates.Recommend new procedures or changes to existing procedures where applicable.Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed.Conduct root cause analysis and implement Corrective Action and Preventative Action (CAPA) process.Support the business on the application and facilitation of quality systems (deviations, notification to management, change control).Support activities and processes related to external party management (such as, third-party organizations, business alliance partners) as assigned.Perform quality self-assessments, as needed.Provide Quality Oversight for business area(s)Monitors and provide quality oversight for compliance to Safety & Efficacy Quality System (SEQS).Communicates and escalates compliance issues to management locally and globally, as appropriate.Provide consultation on the interpretation and practical application of external requirements, standards, and procedures.Ensure implementation of regional and/or affiliate Quality Plan(s) as necessary
-
Quality Specialist In Clinical Safety
hace 2 meses
Alcobendas, España Lilly A tiempo completoAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Clinical Research Associate II
hace 1 semana
Alcobendas, Madrid, España Parexel A tiempo completoJob Overview">Parexel, a leading biopharmaceutical services company, is seeking a Clinical Research Associate II to join its Clinical Operations Team in Spain. This role offers the opportunity to go beyond the typical clinical monitor position and make a meaningful impact on site quality and delivery.About Parexel">We believe in our values of Patients First,...
-
Senior Medical Director
hace 2 meses
Alcobendas, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve. Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic,...
-
Medical Director Lead for Global Safety Operations
hace 1 semana
Alcobendas, Madrid, España Parexel A tiempo completoParexel is a leading provider of biopharmaceutical services that help clients transform scientific discoveries into new treatments. We believe in our values: Patients First, Quality, Respect, Empowerment & Accountability.Job OverviewWe are looking for a Senior Medical Director with extensive experience in Pharmacovigilance / Drug Safety to lead our Safety...
-
Clinical Contract Specialist Lead
hace 6 días
Alcobendas, Madrid, España Parexel A tiempo completoJob DescriptionParexel, a global biopharmaceutical services company, is seeking an experienced Clinical Contract Specialist Lead to join its team in the EMEA region. This role requires fluency in French and English languages.Company OverviewWe are dedicated to improving the world's health by providing innovative solutions that help clients transform...
-
Senior Medical Director
hace 3 meses
Alcobendas, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve.Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments.From clinical trials to regulatory, consulting, and market access, our therapeutic,...
-
Senior Medical Director
hace 2 meses
Alcobendas, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve.Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments.From clinical trials to regulatory, consulting, and market access, our therapeutic,...
-
Senior Medical Director
hace 2 meses
Alcobendas, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve.Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments.From clinical trials to regulatory, consulting, and market access, our therapeutic,...
-
Senior Medical Director
hace 4 meses
Alcobendas, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve. Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our...
-
Director Global Pharmacovigilance
hace 2 meses
Alcobendas, España Teva Pharmaceuticals A tiempo completoApply now » Director Global Pharmacovigilance - Safety Physician Date: Sep 23, 2024 Location: Madrid, Spain, 28108 Company: Teva Pharmaceuticals Job Id: 58386 Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier...
-
Senior Medical Director
hace 3 meses
Alcobendas, España Parexel A tiempo completo.When our values align, there's no limit to what we can achieve.Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments.From clinical trials to regulatory, consulting, and market access, our therapeutic,...
-
Senior Medical Director
hace 1 mes
Alcobendas, España Parexel A tiempo completo.When our values align, there's no limit to what we can achieve. Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic,...
-
Director Global Pharmacovigilance
hace 2 meses
Alcobendas, España Teva Pharmaceuticals A tiempo completoApply now »Director Global Pharmacovigilance - Safety PhysicianDate: Sep 23, 2024 Location: Madrid, Spain, 28108 Company: Teva Pharmaceuticals Job Id: 58386 Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that...
-
Director Global Pharmacovigilance
hace 3 semanas
Alcobendas, España Teva Pharmaceuticals A tiempo completoApply now »Director Global Pharmacovigilance - Safety PhysicianDate: Sep 23, 2024 Location: Madrid, Spain, 28108 Company: Teva Pharmaceuticals Job Id: 58386 Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that...
-
Quality Assurance Coordinator
hace 2 meses
Alcobendas, España Lilly A tiempo completo.At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy...
-
Quality Assurance Coordinator
hace 2 meses
Alcobendas, España Lilly A tiempo completo.At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy...
-
Quality Assurance Coordinator
hace 2 meses
Alcobendas, España Eli Lilly And Company A tiempo completo.At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Regional Clinical Trial Management Associate
hace 4 semanas
Alcobendas, España Beigene A tiempo completoBeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals.When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General Description:Supports the Regional Clinical...
-
Clinical Research Associate Ii
hace 2 meses
Alcobendas, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve.Parexel is in the business of improving the world's health.We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments.From clinical trials to regulatory, consulting, and market access, our therapeutic,...
-
Regulatory Intelligence Specialist
hace 2 meses
Alcobendas, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve. We are seeking a highly motivated and detail-oriented Regulatory Intelligence Specialist to join our team. As a Regulatory Intelligence Specialist, you will be responsible for Regulatory Intelligence activities, ensuring that Parexel stays up to date with regulatory updates and implements...
