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Senior Safety Scientist
hace 1 mes
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 Senior Safety Scientist to join our team in the post-marketing surveillance of our Oncology products.
The Position
As a Senior 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.
