signal detection activities to safety documents, as well as ad hoc Health Authority queries. Act as Subject Matter Expert... reporting databases. Job Description Major accountabilities: Lead the safety signal detection and triage activities...
and contributes trending and safety signal detection and risk management assessment for the products’ life cycle. Provides safety... assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing...
and monitoring of safety signal detection. You will also develop and review medico-scientific communications manuscript and abstract... on Harmonization Good Clinical Practices) and protocol compliance, prioritizing subject safety, and contributing to the success...
, and reliability requirements. Circuit Design & Development: Lead the design, simulation, and analysis of complex analog, mixed-signal..., security and occupational health, safety and environmental policies and procedures. In addition to the duties...
-functional teams to develop comprehensive signal evaluation reports, product risk management files including risk management... and compilation of product post-market data and findings into comprehensive Periodic Safety Update Reports (PSURs) in compliance...