The role involves providing advanced scientific oversight of ICSR and clinical trial SAE evaluation to ensure medical accuracy and regulatory compliance
Job Summary
The role involves providing advanced scientific oversight of ICSR and clinical trial SAE evaluation to ensure medical accuracy and regulatory compliance.
Candidates will lead the development of high-quality case narratives and guide the scientific preparation of regulatory ready case submissions including SUSARs.
The position requires maintaining expert level knowledge of global drug safety regulations such as FDA, EMA, ICH, and CIOMS guidelines.
Matching Summary
The role involves providing advanced scientific oversight of ICSR and clinical trial SAE evaluation to ensure medical accuracy and regulatory compliance.