RP
The Director, Patient Safety Intake and Regulatory Submissions delivers Global Patient Safety (GPS) Department services according to ICH-GCP guidelines, regulatory requirements and Regeneron standard operating procedures (SOPs) and/or project specific procedures. This position is responsible for the oversight of the processes and systems which enable initial Intake of adverse event data (i.e., via electronic database capture (EDC), phone line, etc.), the subsequent reporting of Individual Case Safety Reports (ICSRs) to health authorities, Alliance Partners and internal destinations in compliance with applicable global regulations (ICH-GCP) and contractual obligations, and follow up activities to ensure receipt complete and accurate safety information. This role will lead a global team responsible for all aspects of Intake and ICSR submissions for the company product portfolio covering pre and post marketing activities. This position will also be responsible for the oversight and mainte ...