of pharmacy support personnel's work. Ensures compliance with manufacturer requirements for REMS or other requirements when...
to Investigator Brochures, DSURs, Protocols, ICFs, IBs (including RSI determination), CSRs, CCDS, RMP, REMS etc. Assist...
in development and maintenance of risk management plans and REMS as applicable. Key member on the Product Safety Committee...
, including, pharmaceutical private label products, 3PL, REMS programs, clinical research programs, pharmaceutical and medical...
operations across the US. You will engage in GMP document management and ensure adherence to local regulations, including REMS...
employees. Facilitate research collaborations (including REMS programs, Real World Data [RWD] generation and investigator...
reconciliation documents, CTD modules, REMS, RMP and CSR). Essential Functions: Manages all medical aspects of contracted tasks... and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules...
from other groups, review coordination, and quality checks. Coordinate RMP updates and REMS reports as appropriate. Support regulatory...
, additional risk minimization measure materials, Structured Benefit Risk Assessments, REMS documents and REMS materials...
and expand the business. Expert in the areas of specialty pharmacy including REMS products, oncology, hematology... Enforcement Agency, as well as state and local laws and regulations. Detailed understanding of REMS programs relevant...