REMS programs. This requires establishment of strategic partnerships within R&D organization, staying abreast... Management Plans, including risk minimization measures, risk minimization action plans (RiskMAPS) and REMS programs, as relevant...
REMS programs. This requires establishment of strategic partnerships within R&D organization, staying abreast... Management Plans, including risk minimization measures, risk minimization action plans (RiskMAPS) and REMS programs, as relevant...
around medication safety, medication alerts and recalls, REMS, and other safety-related activities. The individual works...
) Accreditation. Oversees any FDA Risk Evaluation & Mitigation Strategy (REMS) Programs. Helps in contract negotiation and execution...
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...
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...