SUPRAJA BOINA

Regulatory Affairs and Quality Intern

Phone No.:302-***-**** ad4in6@r.postjobfree.com

Accomplished Clinical Pharmacist and Clinical Research Trainee with a robust background in Clinical Research, Pharmacovigilance, and Patient counselling. Excelled at Malla Reddy multi-specialty hospital, showcasing outstanding organizational and analytical skills. Proven track record in improving therapeutic outcomes and streamlining drug therapy processes, demonstrating a solid grasp of GCP, GLP and FDA regulations.

EDUCATION:

Master of Science in Regulatory Affairs Expected Graduation - December 2024

Northeastern University, Boston, MA

Related Course work: Regulatory Compliance, Regulatory Strategy for Product Development and Life Cycle, Management, FDA Pharma Regulation, Advance Regulatory Writing, Global Impact of the eCTD, Therapeutic Product Development, Introduction to Safety Sciences.

Doctor of Pharmacy September 2015- September 2021

Jawaharlal Nehru Technological University, Hyderabad, India

Related Course work: Clinical Research, Pharmaceutical Jurisprudence, Pharmacology, Pharmaceutical Analysis and Pharmaceutical Microbiology

INTERNSHIP EXPERIENCE:

Trainee in CLINICAL RESEARCH AND PHARMACOVIGILANCE Oct 2021-Jan 2022

Clinosol Research Private Limited, Hyderabad, India

Performed quality assurance checks on projects, ensuring compliance with regulations and protocols.

Enhanced professional development through workshops, seminars, and training.

Assisted with administrative tasks.

Developed strong organizational and time management skills in a fast-paced environment.

Supported clinical trial activities by: Developing study documents, providing site visit support, maintaining accurate documentation, conducting informed consent discussions, Monitoring study activities, Collecting and recording accurate data.

Provided pharmacovigilance expertise, including Adverse event reporting and case processing, Analyzing post-marketing surveillance data.

Monitored testing procedures for compliance.

CLINICAL PHARMACIST Malla Reddy hospital, Hyderabad, India Sep 2020-sep 2021

Conducted comprehensive medication reviews to optimize patient therapy, identifying potential adverse drug interactions and duplicate therapies.

Collaborated with healthcare teams on interdisciplinary rounds to provide expert pharmaceutical care consultation.

Maintained a deep understanding of medications through ongoing research of new drugs and treatments, including indications, contraindications, side effects, dosages, and interactions.

Ensured medication safety and accuracy through prescription order evaluation, quality assurance audits, and analysis of prescribing trends.

Managed pharmacy operations efficiently, including maintaining inventory levels, medication records, and implementing safe and compliant medication handling procedures.

Demonstrated commitment to patient privacy and regulatory compliance by adhering to HIPAA regulations.

ACADEMIC PROJECT: August 2019 - February 2020

“Epidemiological Studies on Fractures in Tertiary care Hospital”.

Malla Reddy Multi-specialty Hospital, Suraram, Hyderabad.

Objective: Investigated bone fracture patterns in hospitalized patients to identify risk factors, analyzed causes, affected age groups, and injury distribution patterns and inform treatment strategies.

Methodology: Conducted a prospective observational study of 258 orthopedic patients. Data was collected using case report forms and analyzed with SAS 9.4 software.

Key findings:

Road traffic accidents remain a major cause of bone fractures.

Trauma-related fractures are increasing.

The middle-aged population is most affected.

SKILLS:

•Extensive knowledge in Clinical Research, Pharmacovigilance, Prescription audit and Therapeutic drug monitoring, Clinical Data Management.

•GMP, GLP Knowledge, Organizational Skills, Data Analysis, Task Prioritization, Data Collection Monitoring, Regulatory research, Standard Operating Procedures, Clinical Trial Applications, Clinical Trials Protocols, Audits, EMA Regulations, Clinical Trials Oversight, Continuous Improvement, Regulatory research, Pharmaceutical Industry Knowledge, Interpretation of FDA guidelines.

PUBLICATIONS:

Title: “Epidemiological studies on fractures in tertiary care hospital”. Published in IJSRP, volume 10, Issue 6 publication under ISSN 2250-3153, June 2020.

ACHIEVEMENTS:

•Certification in International Conference on Harmonization – Good Clinical Practice (GCP NIDA)

•Certification of Rendezvous-2017 as a delegate participant and later as coordinator in Elixir-2018, 2019 at college level

•Participated in various poster presentation conducted by Malla Reddy group of institutions:

e-poster on Drug resistance decreased by home medicine.

Poster presentation on Pharmacoeconomics and outcome research

e-poster on Role of clinical pharmacist in managing the risk of Adverse Drug Reactions

•Participated twice in medical camps as Public Health Care Pharmacist

•Participated in CPR workshop conducted at Gandhi Medical college.

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