•Develop and assist with the start up a new company Medical Affairs Call Center•Train and develop Call Center forms and SOP’s•Receive, track & report Clinical and PM Adverse Drug Events •Medical Information Requests•Compile ADE Periodic Reports for submission•Project specific 24/7 after hours call center “on-call” rotation•Research & write standard & non standard medical information letters•Review Clinical Regulatory Documents•Write and present Medical Affairs… Show more •Develop and assist with the start up a new company Medical Affairs Call Center•Train and develop Call Center forms and SOP’s•Receive, track & report Clinical and PM Adverse Drug Events •Medical Information Requests•Compile ADE Periodic Reports for submission•Project specific 24/7 after hours call center “on-call” rotation•Research & write standard & non standard medical information letters•Review Clinical Regulatory Documents•Write and present Medical Affairs Corporate Report•Conduct literature searches•Maintained and oversaw contract consultants & managed patient assistance program when active•Validate and maintain ADE (AERS) system•Ensure compliance with FDA regulations Show less

•Develop & publish clinical trial documentation (Protocols, SOP’s, & Clinical Reports)•Support clinical programs and project managers•Maintain and validate CTM inventory management systems•Clinical Trial Materials (CTM) Auditor•Maintain and oversee clinical trial master file system•Ensure GCP/GMP, FDA regulations & compliance

Track and report adverse drug events as according to SOP's and FDA regulationsMaintain Global Adverse Event Database for signal detection (ARISg)Domestic, foreign, clinical trial SAE as well as litigation reportingPharmacovigilance query and MedDRA database developmentCompany-wide training of mandatory ADE reporting

Track in-house and field Medical Device and serious Adverse Event reports for clinical trialsCompile & create monthly ADE report as a top level synopsis for the Corporate Medical DirectorResearch "F-D-C Reports" weekly for notices concerning safety surveillanceStatistical comparisons between competitor drugs vs. B&L productsADE Database Software Validation AssociateCompile technical specificationsPerformed Operational Qualification (OQ/PQ) testing Write user… Show more Track in-house and field Medical Device and serious Adverse Event reports for clinical trialsCompile & create monthly ADE report as a top level synopsis for the Corporate Medical DirectorResearch "F-D-C Reports" weekly for notices concerning safety surveillanceStatistical comparisons between competitor drugs vs. B&L productsADE Database Software Validation AssociateCompile technical specificationsPerformed Operational Qualification (OQ/PQ) testing Write user manual Show less

•Contributed to design, structure, and maintenance of the ADE databases•Performed system validation of relational Oracle databases•Performed performance qualification (PQ) and acceptance testing of new products•Track and report adverse drug events as according to SOP’s and FDA regulations