Senior Safety Expert

hace 4 semanas


Barcelona, Barcelona, España Https:Www.Energyjobline.ComSitemap A tiempo completo

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.

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