Whether it is in the news, at work, or at home, medicine and pharmaceuticals (as well as the myriad products related to medical care such as devices and diagnostic tests) play a prominent role in the lives of people throughout the world. It is a truly exciting time to practice pharmacy, and the current changes in the healthcare landscape present opportunities for which pharmacists are ideally suited. I am scheduled to graduate (in DEC2022) with a Master's Degree in Pharmaceutical Regulatory Affairs from San Diego State University. Through my studies, I have developed knowledge of:- U.S. FDA regulations (21 CFR) and guidance documents.- Warning Letters and FDA auditing, including understanding of Form 483s.- Clinical trial design and implementation, including ICSRs and Investigator Brochures- IRB and IEC practices- Understanding of Phase 1 through 3 clinical trials- Investigational New Drug (IND), New Drug Applications (NDA), and Biologics License Applications (BLA).- Required post marketing safety monitoring practices. - QA/QC structures and investigations, including cGxPs and CAPA.- Device applications such as IDE, 510(k), and PMA- Global regulatory bodies, such as EMA, as well as harmonization efforts under ICH Presently, I work as a Medical Information Specialist at Alphanumeric Inc., where I provide company- and FDA-approved information to consumers and healthcare providers about products in the Janssen pharmaceutical portfolio. I utilize the Veeva document database according to company SOP. I am also responsible for responding to adverse events (AEs) and product quality complaints (PQCs) received from consumers and medical professionals, and I generate reports through the EZReporter platform. I previously practiced as an authorized nuclear pharmacist (ANP) for Jubilant DraxImage Radiopharmacies providing SPECT radiopharmaceuticals for diagnostic and therapeutic use. Nuclear pharmacy is a specialty dedicated to providing radiopharmaceuticals for imaging studies of a wide variety of organs, and is essential for modern medicine. Through the compounding and dispensing of these products, the nuclear pharmacist enables clinicians to get a better understanding of the physiological state of the patient, which allows the application of effective, evidence-based treatment. Both the science and regulation of the field continue to evolve as new radiopharmaceutical products are developed and tested.
Listed skills include Microsoft Office, Microsoft Excel, Teamwork, Powerpoint, and 13 others.
