Sofia Berardi Email & Phone Number

New Jersey, United States

Titusville, New Jersey, United States

Staten Island, New York, United States

United States

Acute patient care- OncologyAcute patient care- Solid organ transplant Participated in the drug dispensing process and established an understanding of USP 797 and USP 795.

Built a foundation and understanding of the role of the Regulatory Affairs Team within the pharmaceutical industry. Supported the Regulatory Affairs team by researching and analyzing current US drug law and related FDA guidances to support regulatory decision making. Participated in global regulatory affairs team meetings to discuss global regulatory strategies for pipeline products. Monitored and analyzed regulatory intelligence sources (Cortellis, Citeline, Health Authority websites, etc.) Became familiar with FDA submissions, eCTD structure, drug applications (e.g. INDs, NDAs, BLAs, etc.), US labeling, strategic Briefing Book development, navigation of Health Authority websites, clinical trial databases, eCFR (with focus on 21 CFR 312, 314, and 601), labeling (e.g. USPIs), FDA guidances, ICH and EMA guidelines, and FDA expedited programs (e.g. fast track, breakthrough therapy, etc.)Co-authored a Global Standard Operating Procedure (SOP) to describe the activities related to commenting on draft guidances and regulations. Contributed to a presentation on the key label claims of a developing immunology product by supporting primary and secondary endpoint selection and collecting precedent of drug approvals and competitor pipeline drugs.

Provided medication reconciliation to patients via Telehealth and in office while collaborating with pharmacists and physicians to provide optimal therapeutic interventions for patients. Worked on prior authorizations in order obtain drug approval for patients. Developed education materials for patients as well as physicians in order to educate on commonly prescribed medications.

Staten Island, New York, United States

During my time at South Beach Psychiatric Center, I assisted in gathering accurate medication histories to complete patient medication reconciliations. I also processed and prepared medications for patients.

Staten Island, New York, United States

At Super Health Pharmacy, I participated in the prescription order entry, fill, and dispensing process. I provided medication therapy management and counseling services for patients regarding Rx medications, OTC products, and medical devices, while establishing close relationships with patients and promoting products and services of the pharmacy. I also communicated with insurance companies and physicians to resolve medication issues and obtain prior authorizations.

Staten Island, New York, United States

Schedule reservations for patrons utilizing OpenTable and coordinated activities of dining room personnel.

Doctor Of Pharmacy - Pharmd, Pharmacy

Activities and Societies: Industry Pharmacist Organization (IPhO), Pennsylvania Pharmacist Association (PPA), American Pharmacist.

High School Diploma