Manju Bhargavi Gaddameedi
Plymouth,MA
Summary
Possess a full understanding of all applicable FDA legislation, as well as any regulations and guidelines that pertain to clinical research. dedicated to facilitating the efficient conclusion of clinical investigations and ensuring compliance. shown ability to effectively assist clinical research projects as they are being carried out. a history of paying meticulous attention to detail and maintaining organized records. Looking for a clinical research internship to benefit from regulatory expertise and help with reaching research milestones.
Overview
1
1
year of professional experience
1
1
Certification
Work History
Intern
Narayana Hrudayalaya Hospital
09.2020 - 09.2021
- ·Assisted physicians in patient counseling sessions.
- Analyzed and Presented Case studies and participated in posture presentations
- Determining adverse medication responses, conducting case studies, identifying prescription errors, and sending case report forms to the internal pharmacovigilance division.
- Participated in hospital ward rounds for a year in a variety of departments.
- Participated in a prospective observational study on 300 subjects (post-surgical orthopedic patients) in a tertiary care hospital to assess the Rational usage of Antibiotics and presented at an International Conference where it got picked and published by Young Pharmacist
Education
Master of Science - Regulatory Affairs
Northeastern University
Boston, MA03.2024
Bachelor of Science - Doctor of Pharmacy (PharmD)
Jawaharlal Technological University
India09.2021
Skills
Regulatory Competencies:
- Thorough knowledge of GCP (Good Clinical Practice), IRB meetings, the significance of study protocol in clinical trials, ICF (Informed Consent form), and clinical safety data management
- Comprehensive understanding of US FDA and EU EMA Regulations, ICH Guidelines, 21 CFR
- Through knowledge of Regulatory Compliance, Good Clinical Practice, 510k, PMA, Labeling, Packaging, Post-market Requirements, the process of IND & NDA submissions
- Accustomed to FDA Guidance, Federal Register, ClinicalTrialsgov, MAUDE Database, Med Watch AE Reporting
Accomplishments
Academic projects:
- Case Study on Adaptive clinical trials
- Regulatory strategy for the commercialization plan of a New Drug (Magic dust)
- Informed Consent Form for a Diabetic Drug
- Presented FDA’s role in Prescription Drug Advertising
- Analysis of Cellular Gene Therapy as an Emerging Issue in Therapeutic Product Development
- FDA Inspections and Legal Instances
- Pre-market SUSAR reporting for ITCA-650
- Presented REMS strategy-Zyprexa Relpreve Injection
Certification
Good Clinical Practice
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Intern
Narayana Hrudayalaya Hospital
09.2020 - 09.2021
Master of Science - Regulatory Affairs
Northeastern University
Bachelor of Science - Doctor of Pharmacy (PharmD)
Jawaharlal Technological University
Good Clinical Practice
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