Vp, Head Of Clinical Safety Management And Portfolio Manager
CurrentDevPro Biopharma is a Clinical Research and Development Accelerator with the mission to design, develop, and deliver molecules into medicines.
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Pramila Monte, Bsn, Mba is listed as VP, Head of Clinical Safety Management and Portfolio Manager at DevPro Biopharma, based in Montville, New Jersey, United States. AeroLeads shows a work email signal at astrazeneca.com and a matched LinkedIn profile for Pramila Monte, Bsn, Mba.
Pramila Monte, Bsn, Mba previously worked as Director, Clinical Trial Safety Management at Astrazeneca and Associate Director of Pharmacovigilance at Pearl Therapeutics Inc. (A Member Of Astrazeneca). Pramila Monte, Bsn, Mba holds Nursing from University Of Medicine And Dentistry Of New Jersey.
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A strategic and progressive leader with over 15 years of experience overseeing pharmacovigilance, clinical safety management, and global health authority inspections.A key leader in transforming organizational efficiency by introducing new innovations, standardization, and process improvements. Integral part of advancing organizations through establishing a clear vision, implementing new processes, and leading high-performing teams.
Listed skills include Pharmacovigilance, Clinical Trials, Pharmaceutical Industry, Gcp, and 7 others.
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Basking Ridge, Nj, Us
DevPro Biopharma is a Clinical Research and Development Accelerator with the mission to design, develop, and deliver molecules into medicines.
Cambridge, Cambridgeshire, Gb
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)
St-Prex, Ch
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
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Pramila Monte, Bsn, Mba works for DevPro Biopharma.
Pramila Monte, Bsn, Mba is listed as VP, Head of Clinical Safety Management and Portfolio Manager at DevPro Biopharma.
AeroLeads has found 1 work email signal at @astrazeneca.com for Pramila Monte, Bsn, Mba at DevPro Biopharma.
Pramila Monte, Bsn, Mba is based in Montville, New Jersey, United States while working with DevPro Biopharma.
Pramila Monte, Bsn, Mba has worked for Devpro Biopharma, Astrazeneca, Pearl Therapeutics Inc. (A Member Of Astrazeneca), Pearl Therapeutics, and Ferring Pharmaceuticals.
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Pramila Monte, Bsn, Mba holds Nursing from University Of Medicine And Dentistry Of New Jersey.
Pramila Monte, Bsn, Mba is listed with skills including Pharmacovigilance, Clinical Trials, Pharmaceutical Industry, Gcp, Medical Writing, Clinical Research, Regulatory Affairs, and Clinical Development.
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