Safety Surveillance Analytical Specialist ensuring robust signal detection in safety surveillance for a growing portfolio in life sciences. Analyzing safety data and improving signal detection methodology under expert guidance.
Responsibilities
Leading and further developing signal detection and signal validation analysis strategies ensuring consistency across studies and therapeutic areas
Acting as a methodological expert and advisor on signal detection approaches, including statistical, trend based and exploratory methods, and their applicability to different data sources
Supporting and improving the signal detection process, including governance, and documentation
Providing expert input into surveillance plans, analysis plans, and responses to complex internal or Health Authority requests
Contributing to the definition of requirements for analytical tools and surveillance systems used in signal detection
Driving continuous improvement initiatives related to signal detection methodology, and processes
Delivering training and guidance to colleagues on signal detection methodology, analysis strategies, and best practices within clinical trial surveillance
Requirements
A master’s degree in life- or natural sciences
Solid experience in safety surveillance and signal detection
Demonstrated expertise in signal detection methodology, analysis strategies, and interpretation of complex safety data
Sound understanding of the signal management lifecycle and relevant regulatory frameworks (e.g., GVP and GCP)
Experience translating scientific and analytical concepts into clear guidance, processes, and training material
Strong stakeholder management skills and the ability to work independently in a senior expert role
Comfort advising and influencing across organizational boundaries
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