and compliance Educate patients on injectable therapies and REMS programs Support new referrals and maintain complete documentation...
. - Must reside within a commutable distance of Cary, NC. Purpose The Clinical Case Risk Evaluation and Mitigation Strategy (REMS... and educate new/existing patients on specialty drug therapies existing patients on REMS FDA-mandated medications...
and product safety reports (e.g., Annual Reports, DSUR, PSUR, REMS Annual Report, Supplements, Technical Documentation File..., REMS Annual Reports and audits), product approval process, and post-market surveillance Proficient written and verbal...
with GPS Medical Directors Project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs...
including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration safety physicians. Responsible...
or observations REMS, Manufacturer & Limited Distribution Drug (LDD) Support Partner with REMS administrators to ensure REMS... compliance and conduct routine internal audits Support quality requirements associated with REMS programs, limited distribution...
policies, 340B program (if applicable), accrediting bodies, REMS compliance, third-party payers (including audits), and state...
and management on as needed basis Adhere to REMS program guidelines and requirements Fulfillment of prescriptions including...
with patient care and medication ordering from various pharmacies to each center Maintaining compliance with REMS, DEA, Med log...
with retail pharmacy products Orphan/rare disease therapeutic sales experience a benefit REMS/hub or central pharmacy experience...