
Michael Azer
Pharmacist

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About me
Pharmacist/Management Analyst at FDA
Education

Florida Agricultural and Mechanical University
2006 - 2012Doctor of Pharmacy (PharmD) PharmacyGraduated with honors, magna cum laude. Frequently on College of Pharmacy's Dean's list.
Experience

Southwest Surgical Hospital
Dec 2012 - Aug 2015PharmacistClinical Pharmacist managing drug regimens of patients under surgical care. Clinical oversight to patient's pre-operative, intra-operative, and post-operative medications. Supervise daily operations. Supervise technicians throughout daily operations. DUR of each patient daily. Critical committee member in the start of Omnicell and training to all staff. Understand and carry out frequent reports in Omnicell system database. Attend to specific reports request regarding daily operations and specific scenarios. Critical committee member in starting electronic order entry process. Manage recalled drugs and quality assurance in the pharmacy. Critical member and leader in JCAHO preparation of inspection with 100% score on site visit. Critical member in State Board of Texas inspection and 100% score with no penalties or markings on site visit. Manage and oversee all narcotics used in surgical cases with proper documentation and reconciliation by Anesthesiologist's and CRNA's. Project-planning member in pharmacy and clinical services. Attend and assist meetings, both daily and monthly with varying appointments. Work directly under the Chief Clinical Officer and offer insight to more efficient operations. Properly manage formulary and inventory for budgeting and clinical purposes. Work directly with physicians insuring patients receive optimal care. Manage patients medications throughout hospital and surgical care. Formerly interim Director of Pharmacy. Show less

Walmart
Dec 2012 - Jan 2016PharmacistEnsure patients receive optimal care in a community pharmacy setting. Supervise daily pharmacy operations. Patient counseling. Manage and supervise pharmacy technicians and any entity entering the pharmacy at any given time. Supervise narcotic usage. Assure patients receive correct medication in the correct bottle with a correct and complete prescription appropriate for the patient's condition and well-being. Provide insight to prescribers and patients about medications and optimal drug therapy.

Cardinal Health
Feb 2015 - Jan 2016PharmacistLearn and operate several hospital and rehabilitation facilities operating systems in order to process clinical orders remotely. Troubleshoot technology-related issues in regards to hospital’s pharmacy operating system to nurses and supervisors remotely, i.e. Pyxis or Omnicell machines having communication errors with hospital pharmacy system resulting in nurse being unable to dispense medication to patient at a critical time. Review clinically-relevant information per patient remotely that includes: Prospective DUR (drug utilization review), Retrospective DUR, Clinical interactions in relation to drug-drug, drug-food, drug-allergy. Consult with physicians and nursing units to optimize patient hospital stay remotely. Dose medications based on patient’s condition as requested per physician. Vancomycin pharmacy to dose, Aminoglycosides pharmacy to dose, Quinolones pharmacy to dose, Beta-lactams pharmacy to dose. Review and make dosing recommendations as requested per physician. Train co-workers on information technology and related-issues for specific hospitals. Train co-workers on hospital pharmacy system in order for medications to be processed by pharmacist. Train co-workers how to respond to technological issues with each specific hospital, i.e. Medication dispensing cabinet is not communicating correctly with hospital pharmacy system. Show less

FDA
Jan 2016 - nowRegulatory Business Process Manager (RBPM): Serve as a centralized project manager for the quality assessment of applications (NDA and ANDA). Serves as a project manager for a variety of team-based projects. Manages activities of the team, including scheduling meetings, preparing agendas and official records of meetings, tracking tasks and project milestones, and holding project briefings with senior management or other groups as appropriate. Collaborate with the supervisor, senior management, and the lead project manager to identify, document, and coordinate projects and provides consultation on project requirements. Implements corporate decisions, guidance, laws, regulations, and policy in the development of projects. Source of contact and support for current regulatory guidelines and policies to sponsors and pharmaceutical firms. Control and maintain project milestones throughout the full project life cycle by participating in the planning, requirements development, and design, development, and implementation phases. Communicate and discuss specific post-marketing topics with team review members, branch chiefs, and other review staff to ensure post-marketing changes are completed and are to par with completion dates. Serve as a source of contact within the FDA for all quality-associated post-marketing supplements being managed. Maintain active communication and serve as liaison between FDA and firms/patent holders by means of NDA and ANDA-related correspondences. Maintain contact and working relationships within all elements of the Center with respect to future project activities. Facilitate timely completion of project activities and attainment of project goals with established project plans and performance goals set up by the team or management. Represent the office as the primary point of contact for assigned projects with Congressional interests, the external organizations, and higher authorities. Show less
Management Analyst
Sept 2018 - nowProject Specialist
Sept 2018 - Apr 2019Regulatory Business Process Manager
Jan 2016 - Sept 2018
Licenses & Certifications

Registered Pharmacist
Florida Board of Pharmacy
Registered Pharmacist
Texas State Board of Pharmacy
Honors & Awards
- Awarded to Michael AzerFDA Honor Award - Institutional Review Board (IRB) Inspection Protocol (IP) FDA - Associate Commissioner for Regulatory Affairs Jul 2024 Leadership and initiative in developing the first bioresearch monitoring inspection protocol for use by Office of Bioresearch Monitoring Operations investigators.
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