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Senior Safety Expert
hace 2 meses
About Daiichi Sankyo Europe
Daiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.
Our Mission
We strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with cancer and protecting people from cardiovascular disease, the leading cause of death in Europe.
Job Summary
We are seeking a highly qualified Senior Safety Scientist to join our team in Munich, Germany. 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 teams.
Key Responsibilities
- Support Quizartinib product maintenance during post-marketing, including post-marketing risk management activities (RMP, aRMM), 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, and support of the PSMF generation for product-related information.
- Support risk management and Safety communication, including implementation of strategy for risk minimization, support of product safety physician for signal detection, development of strategy for communication of safety information, and development of safety communication documents and aggregate safety reports.
- Responsible for Signal Tracking and Deviation Management with safety-related activities (e.g. RMP).
Requirements
- Bachelor's degree at 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, clinical safety & PV knowledge, project management, and working in a global matrix environment.
- Oncology product experience is preferred.
- Fluent English in written and spoken.
What We Offer
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 additionally like to work in a multi-cultural and international cooperation, then you are the right person for us.
