JANET ELIZABETH ABRAHAM

ad45j1@r.postjobfree.com LinkedIn 669-***-**** Boston, MA

EDUCATION

Northeastern University Boston, MA Expected Graduation: May 2025 Master of Science in Regulatory Affairs GPA: 4.0/4.0 Relevant Courses:

Regulatory Compliance, FDA Pharmaceutical Regulation, Regulatory Strategy for Product development and lifecycle management, Safety sciences, Human experimentation: methodological issues fundamentals. Rajiv Gandhi University of Health Sciences Karnataka, India Aug 2016 – Jan 2023 Doctor of Pharmacy (PharmD) CGPA: 7.6

Relevant Courses:

Clinical Research, Pharmacology, Biostatistics & Research Methodology, Clinical Pharmacy, Pharmaceutical Jurisprudence, Biopharmaceutics & Pharmacokinetics, Clinical Toxicology, Pharmacotherapeutics, Epidemiology, Pharmaceutical Analysis Projects:

Assessment of Awareness of Breast Cancer and Breast Self-Examination June 2021- Nov 2021 Basaveshwar Teaching and General Hospital, Kalaburagi

• Collaborated in a team of four to curate articles on breast cancer awareness, showcasing effective teamwork, and research skills. Designed informative materials and led impactful awareness sessions for college students, emphasizing preventive measures and contributing to enhanced understanding and awareness. EXPERIENCE

Internship Jan 2022 - Jan 2023

Basaveshwar Teaching & General Hospital, Kalaburagi

• Completed hospital rotations in Medicine (6 months), Orthopedics (2 months), Pediatrics (2 months), and Surgery (2 months), gaining diverse clinical exposure.

• Actively participated in ward rounds, engaging with doctors and interns, contributing to detailed discussions on patient cases, disease explanations, and medication insights.

• Conducted thorough patient history collections in the outpatient department and reported vitals to postgraduate doctors for comprehensive patient evaluation.

• Demonstrated expertise in medication management, performing detailed reviews of charts, ensuring adherence, assessing for drug interactions and adverse effects, and promptly addressing medication errors.

• Executed a patient-centric approach by providing counseling on disease understanding, lifestyle modifications, and discharge medications, actively contributing to ongoing learning through the systematic collection and reporting of four cases monthly, presenting findings to lecturers for comprehensive medical knowledge dissemination. CERTIFICATIONS

• Certificate Course in Drug Regulatory Affairs (DRA) from Udemy Attained a holistic understanding of regulatory terminology, essential professional qualities, and regulatory objectives, while applying key concepts such as INDA, NDA, ANDA. Emphasized expertise in Good Manufacturing Practices (GMP) and Current Good Manufacturing Practices (cGMP).

• Drug Discovery - University of California San Diego Gained insights into various facets of pharmaceutical exploration, including pharmacology, drug development, clinical development, and pharmacokinetics

• Drug Development - University of California San Diego Developed expertise encompassing clinical research, clinical trial design, and the processes of clinical development.

• Drug Commercialization - University of California San Diego Explored key facets of the course, covering Pharmacoeconomics, marketing strategy, intellectual property strategy

• Clinical Trials Management and Advanced Operations - Johns Hopkins University Learned to recognize and address problems and adverse events, ensure regulatory compliance, and actively participate in initiatives promoting transparency in clinical trials. SKILLS

Regulatory/Technical: Microsoft PowerPoint, Word, Excel, Quality Management, Data Analysis, Problem Solving, Project Management, Documentation Writing (NDAs, SOPs, INDs), Clinical Trials Management, Risk Management Laboratory: Microbiology, Paper Chromatography, Thin Layer Chromatography, Pharmacology, HPLC