Senior Safety Expert
hace 4 semanas
About Us
At Daiichi Sankyo, we are dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
Position Available
We are seeking a highly qualified candidate to fill the position of Senior Safety Scientist (m/f/x).
The Position
As a safety scientist, you will provide scientific expertise and support proactive safety surveillance and risk management activities in conjunction with the Product Safety Lead Physician for Quizartinib and cross-functional team(s) in support of benefit risk profile during the post-marketing phase.
Key Responsibilities
Support Quizartinib product maintenance during post-marketing including:
- Support of post-marketing risk management activities (RMP, aRMM)
- Support generation of periodic reports (PSUR, Regional aggregate reports) and responses to health authority requests
- Collaborate with Product Safety Lead for set-up and analysis of Post-marketing studies/registries
- Review of scientific literature
- Support of the PSMF generation for product-related information
- Risk Management and Safety Communication: Support for implementation of strategy for risk minimization
- Support of product safety physician for signal detection
- Development of strategy for communication of safety information
- Development of safety communication documents and aggregate safety reports
- Responsible for Signal Tracking and Deviation Management with safety-related activities (e.g. RMP)
Professional Experience and Personal Skills
Bachelor's degree at a minimum required; PharmD or PhD preferred. Professional experience of at least 5–7 years in a similar position within the pharmaceutical industry. Experience in summarizing and presenting safety data. Possesses strong clinical safety & PV knowledge. Experience in project management and working in a global matrix environment. Experience in International, European, and Pharmacovigilance laws. Oncology product experience is preferred. Fluent English in written and spoken. We are looking for a flexible, stress-resistant team player who can work reliably also under time pressure. Your thinking is analytical and structured; your work style shows a high level of responsibility and quality consciousness. If you, in addition, like to work in a multi-cultural and international cooperation, then you are the right person for us.
-
Product Safety Expert Senior
hace 3 semanas
Barcelona, Barcelona, España Dsm Nutritional Products A tiempo completoJob Title: Senior Product Safety ExpertJob Summary:We are seeking a highly skilled Senior Product Safety Expert to join our team at DSM Nutritional Products. As a Senior Product Safety Expert, you will be responsible for ensuring the compliance of product safety information for the DSM-Firmenich product portfolio. This includes ensuring full legal compliance...
-
Senior Automotive Safety Expert
hace 3 días
Barcelona, Barcelona, España INVENSITY GmbH A tiempo completoAbout the RoleWe are seeking a Senior Automotive Safety Expert to join our team at INVENSITY GmbH. As a key member of our consultancy, you will play a crucial role in designing and implementing safety concepts for driving functions, contributing to the reduction of traffic accidents and fatalities worldwide.Key ResponsibilitiesCollaborate closely with...
-
Senior Global Program Safety Team Lead
hace 4 semanas
Barcelona, Barcelona, España Novartis A tiempo completoJob Description SummaryAre you a seasoned safety clinician looking to drive impactful results at Novartis? As the Senior Global Program Safety Team Lead for Radioligand Therapy, you will be at the forefront of our Medical Safety organization, ensuring robust safety risk management and making a positive impact on our development programs.Key...
-
Safety Leader, Global Patient Safety Expert
hace 4 semanas
Barcelona, Barcelona, España Https:Www.Energyjobline.ComSitemap A tiempo completoJob Summary: We are seeking a highly skilled Safety Leader, Global Patient Safety Expert to join our team at Https:/Www.Energyjobline.Com/Sitemap. As a key member of our Global Patient Safety team, you will play a critical role in evaluating and managing risk within the global regulatory framework.Key Responsibilities:Manage safety scientist activities...
-
Senior Global Program Safety Team Lead
hace 4 semanas
Barcelona, Barcelona, España Advanced Accelerator Applications (Italy) - S... A tiempo completoAbout the RoleAre you ready to lead the charge in improving patients' lives and driving impactful results at Advanced Accelerator Applications? As the Senior Global Program Safety Team Lead, you will be at the forefront of our Medical Safety organization, ensuring robust safety risk management and making a positive impact on our development programs.Key...
-
Medical Safety Expert
hace 4 semanas
Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the Role:This position is part of the Medical Safety organization at Novartis Farmacéutica, responsible for ensuring the safety of patients and ensuring optimal patient safety for assigned compounds.Key Responsibilities:Monitor the clinical safety of projects/products, including literature review, evaluation of individual cases or signal detection,...
-
Safety Implementation Expert
hace 2 semanas
Barcelona, Barcelona, España Veeva Systems A tiempo completoTransform the Life Sciences Industry with Veeva Systems.About the RoleVeeva Systems is a pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.Veeva is looking for an experienced...
-
Medical Safety Expert
hace 4 semanas
Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the Role:This position is part of the Medical Safety organization at Novartis Farmacéutica, responsible for ensuring the safety of patients and ensuring optimal patient safety for assigned compounds.The Medical Safety Lead will provide robust safety evaluation expertise and medical innovation to improve patients' lives and impact overall Novartis...
-
Senior Global Program Safety Team Lead
hace 4 semanas
Barcelona, Barcelona, España Novartis A tiempo completoJob Description SummaryAt Novartis, we are committed to improving patients' lives and driving impactful results. As the Senior Global Program Safety Team Lead, you will be at the forefront of our Medical Safety organization, ensuring robust safety risk management and making a positive impact on our development programs.Key Responsibilities:Manage an...
-
Senior Product Safety Specialist
hace 4 semanas
Barcelona, Barcelona, España Dsm A tiempo completoJob Title: Senior Product Safety ExpertJob Summary:We are seeking a highly skilled Senior Product Safety Expert to join our team at Dsm. As a key member of our Safety, Health, Environment & Security organization, you will be responsible for ensuring the compliance of product safety information for our product portfolio.Key Responsibilities:Maintain data for...
-
Senior Safety Engineer
hace 4 semanas
Barcelona, Barcelona, España Airbus Group A tiempo completoJob Summary:As a Senior Safety Engineer at Airbus Group, you will be responsible for generating and reviewing Safety Assessments and Analyses for various systems, including the Bleed System, Exterior Lights System, Auxiliary Power Unit System, and Fuel Tank Inerting System. You will also support System Design Teams and suppliers to ensure compliance against...
-
Senior Safety Scientist
hace 4 semanas
Barcelona, Barcelona, España Daiichi Sankyo Europe A tiempo completoWe are seeking a highly qualified Senior Safety Scientist to join our team at Daiichi Sankyo Europe. As a safety scientist, you will provide scientific expertise and support proactive safety surveillance and risk management activities in conjunction with the Product Safety Lead Physician for Quizartinib and cross-functional team(s) in support of benefit-risk...
-
Medical Safety Expert
hace 4 semanas
Barcelona, Barcelona, España Novartis A tiempo completoJob Summary:We are seeking a highly skilled Medical Safety Lead to join our team at Novartis. As a key member of our Medical Safety organization, you will be responsible for providing robust safety evaluation expertise and medical innovation to improve patients' lives and impact overall Novartis results.About the Role:This role requires close collaboration...
-
Senior Safety Scientist
hace 4 semanas
Barcelona, Barcelona, España Https:Www.Energyjobline.ComSitemap A tiempo completoAbout UsAt Daiichi Sankyo, we are dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.Position AvailableWe are seeking a highly qualified Senior Safety Scientist to join our team...
-
Senior Implementation Expert
hace 1 día
Barcelona, Barcelona, España Veeva Systems A tiempo completoJob DescriptionWe are seeking a highly skilled Senior Implementation Expert to join our Safety Professional Services team at Veeva Systems.This is an exciting opportunity for an experienced professional with a passion for technology and life sciences implementation.The ideal candidate will have a strong background in Drug Safety, Pharmacovigilance, or...
-
Senior Safety Partnerships Manager
hace 6 días
Barcelona, Barcelona, España Mygwork A tiempo completoRole OverviewWe are seeking a Senior Safety Partnerships Manager to join our team, responsible for building connections with industry, academia, and safety stakeholders to promote research, gain insights, and gather actionable data. This role will work closely with other product managers and developers to make our products safer.Key ResponsibilitiesBuild...
-
Senior Global Program Safety Team Lead
hace 4 semanas
Barcelona, Barcelona, España Advanced Accelerator Applications (Italy) - S... A tiempo completoJob SummaryAs a Senior Global Program Safety Team Lead, you will be responsible for leading the safety management of our Radioligand Therapy (RLT) programs. You will work closely with cross-functional teams to ensure the safe development and delivery of our therapies.Key Responsibilities:Develop and implement safety strategies for RLT programsLead the safety...
-
Senior Software Engineer, Trust and Safety Expert
hace 4 semanas
Barcelona, Barcelona, España Rover A tiempo completoAbout the RoleWe are seeking a skilled Senior Software Engineer to join our Trust and Safety team at Rover. As a key member of our engineering team, you will play a crucial role in fostering trust and ensuring safety within our vibrant community of pet owners and care providers.About the TeamOur mission is to protect and empower our users by verifying...
-
Senior Product Safety Specialist
hace 3 semanas
Barcelona, Barcelona, España Dsm A tiempo completoAbout the role:We are seeking a highly skilled Senior Product Safety Specialist to join our team at DSM. As a Senior Product Safety Specialist, you will be responsible for ensuring the compliance of product safety information for the DSM product portfolio. This will involve ensuring full legal compliance regarding Safety Data Sheets and product...
-
Senior Clinical Safety Scientist
hace 4 semanas
Barcelona, Barcelona, España Daiichi-Sankyo Europe A tiempo completoAbout the Role:We are seeking a highly skilled Senior Clinical Safety Scientist to join our team at Daiichi Sankyo Europe. As a key member of our Clinical Safety department, you will play a critical role in supporting the proactive safety surveillance and risk management for assigned clinical studies.Key Responsibilities:Evaluate safety data of any source to...