Sr. Director, R&D Quality
Safety and PV supporting key activities for PSMF compliance, REMS development, and commercial product safety (SMT and PSRC...
Safety and PV supporting key activities for PSMF compliance, REMS development, and commercial product safety (SMT and PSRC...
Work with REMs and engagement managers across LOBs and functions, and with other responsible parties, to coordinate...
Responsibilities: Computer System Validation = Supporting and Validating Regulatory systems like REMS RIMS... of Regulatory systems like Regulatory Information Management System, REMS, Publishing, eCTD systems used in pharmaceutical industry...
regarding patients in psychiatric urgencies Perform administrative functions such as clinical charting, REMS/cures monitoring...
as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR). General Support: Ensures... and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules...
and/or review of the RMP/REMS documents and their maintenance, in collaboration with the safety sciences function Prepares...
Responsibilities and Requirements: Supporting and Validating Regulatory systems like REMS RIMS 5+years...' experience in Computer System Validation of Regulatory systems like Regulatory Information Management System, REMS, Publishing...
Responsibilities: Supporting and Validating Regulatory systems like REMS RIMS. 10+years' experience... in Computer System Validation of Regulatory systems like Regulatory Information Management System, REMS, Publishing, eCTD systems...
Responsibilities: Supporting and Validating Regulatory systems like REMS RIMS. Computer System Validation... of Regulatory systems like Regulatory Information Management System, REMS, Publishing, eCTD systems used in pharmaceutical industry...
(REMS). The Registered Pharmacy technician may also assist with compounding, preparation and distribution of pharmaceutical..., pharmacy orders and inventory computer systems, investigational or REMS medication management, pharmacy automation software...