DevPro Biopharma is a Clinical Research and Development Accelerator with the mission to design, develop, and deliver molecules into medicines.

Led the implementation of Clinical Trial Safety Management (CTSM) department as part of the Respiratory 2020 transformation initiative enabling efficient and consistent management of clinical safety for all Late RIA portfolio with successful database locks for over 15 studies.Successfully led global execution of safety management components for 5 major Health Authority inspections by FDA, PMDA (Japan), EMA, and CFDI (China), which culminated in bringing respiratory medicines to market: BREZTRI® AEROSPHERE and BEVESPI® AEROSPHERE

Developed Pharmacovigilance (PV) organization for Pearl Therapeutics, delivering vision, implementing key business objectives, strategic planning, vendor identification and oversight, centralizing SAE case processing and managing committees including Clinical Endpoint Committees (CEC) and Data Monitoring committees (DMC)

Led development, implementation and oversight of new call center and safety database. Drove user requirements, system upgrades, database mapping, and led the rollout of new IT tools and system upgrades.Triaged, processed and QC all case types for accuracy and labeling (Clinical Trials, Devices, Literature, Spontaneous, and Solicited).Trained and mentored new PV SpecialistPrepared local SOPs and Work Instructions