) Accreditation. Oversees any FDA Risk Evaluation & Mitigation Strategy (REMS) Programs. Helps in contract negotiation and execution...
products specific to CNS/neuroscience, including epilepsy, is desired. New product launch experience Specialty pharmacy/REMS...
and Mitigation Strategies (REMS), and other safety monitoring strategies. Collaborate with internal and external stakeholders...
, formulary request process and presentation to P&T committee(s), evaluate off label/exception review, REMS programs...
, formulary request process and presentation to P&T committee(s), evaluate off label/exception review, REMS programs...
, 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...
management strategies (REMS, Risk Management Plan, Post-Approval Safety Surveillance, Enhanced Pharmacovigilance...
Health policies, 340B program (if applicable), accrediting bodies, REMS compliance, third-party payers (including audits...
with preauthorization and reimbursement documentation, and schedule patient visits. Submit REMS monitoring forms for Spravato treatments...
. Detailed understanding of REMS programs relevant to specialty pharmaceutical products. Understands the limited distribution...