, CTD modules, REMS, RMP and CSR). General Support: Ensures tasks delegated to pharmacovigilance are properly executed..., IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical...
but are not limited to: handling oral oncology medications, prescription verification, REMS compliance, dispensing, distribution...
and expand the business. Expert in the areas of specialty pharmacy including REMS products, oncology, hematology... understanding of REMS programs relevant to specialty pharmaceutical products. Understands the limited distribution process...
laws and regulations. Detailed understanding of REMS programs relevant to specialty pharmaceutical products...
Administration (FDA) REMS Program requirements for KYMRIAH Chimeric Antigen Receptor (CAR) T-cell Therapy. Ensures NCH, DE adheres...
in this position works closely with the REMS team which includes the Associate Directors, Regional Associate Director of Engineering... operations to maintain efficiency. Act as a liaison between the Regional Director and REMS staff. Support onboarding...
, clinical guidelines, pharmacology, REMS programs, etc. Minimum Qualifications: Bachelor's Degree in Pharmacy or Doctorate...
individual in this position works closely with the REMS team which includes the Associate Directors, Regional Associate Director... Director in daily operations to maintain efficiency. Act as a liaison between the Regional Director and REMS staff. Support...
Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS), as well as other activities related...
& Patient services o Copay Assistance o Free dispense o Rems data (Good to Have) * Data sources o Veeva Data (CRM, Network...