Job Description
Regeneron is seeking a Director, ICSR Knowledge & Process Optimization to join our organization.
**In this role, a typical day might include:**
The Director of ICSR Knowledge & Process Optimization is accountable for developing, maintaining, and continuously improving global procedures, standards, and tools that enable high-quality, compliant, and efficient individual case safety report (ICSR) processing and adverse event reporting across both developmental and marketed products. This role ensures end-to-end ICSR process robustness—from intake through expedited submissions and periodic reporting—by driving harmonized procedures, risk-based quality controls, and technology-enabled automation. The Director partners closely with GPS Standards and Training, Signal Management, Safety Sciences, Clinical Development, Quality/QA, Regulatory, Medical Information, IT, and Commercial to ensure timely compliance with global regulations while advancing operational excellence.
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**In this role, a typical day might include:**
The Director of ICSR Knowledge & Process Optimization is accountable for developing, maintaining, and continuously improving global procedures, standards, and tools that enable high-quality, compliant, and efficient individual case safety report (ICSR) processing and adverse event reporting across both developmental and marketed products. This role ensures end-to-end ICSR process robustness—from intake through expedited submissions and periodic reporting—by driving harmonized procedures, risk-based quality controls, and technology-enabled automation. The Director partners closely with GPS Standards and Training, Signal Management, Safety Sciences, Clinical Development, Quality/QA, Regulatory, Medical Information, IT, and Commercial to ensure timely compliance with global regulations while advancing operational excellence.
...
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