Senior Safety Scientist
hace 4 semanas
We 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 profile during 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)
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
- 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 like to work in a multi-cultural and international cooperation, then you are the right person for us.
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