Radhika Yanamala
Bangalore
Summary
Detail-oriented Doctor of Pharmacy (PharmD) graduate with a strong background in pharmacovigilance, drug safety, and regulatory compliance. Experienced in accurately entering adverse event reports, crafting patient narratives, conducting MedDRA coding, and conducting literature screenings. Possesses a comprehensive understanding of causality assessment, SAE/SUSAR reporting, and the preparation of periodic safety reports. Excited to contribute to drug safety operations within a fast-paced regulatory environment.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Clinical Research and Pharmacovigilance Intern
Learning Lab Research Institute (LLRI)
04.2024 - 09.2024
- Gained hands-on experience in clinical trial setup and management
- Conducted data entry of adverse event reports and processed ADR cases
- Assisted in MedDRA coding, patient narrative writing, and ICSR processing
- Drafted clinical study reports and supported the review of Periodic Safety Reports (PSRs)
Clinical Pharmacist Intern
Fathima Institute of Medical Sciences (FIMS)
06.2023 - 05.2024
- Monitored and reviewed 50+ patient therapy plans, ensuring 95% adherence to medication guidelines
- Conducted 30+ drug utilization reviews, optimizing pharmacotherapy and reducing ADR occurrences
- Educated patients on medication adherence, improving treatment compliance
- Partnered with healthcare professionals to implement evidence-based pharmacotherapy strategies
Research Lead
Fathima Institute of Medical Sciences (FIMS)
10.2022 - 03.2023
- Led a prospective observational study analyzing 120 neonatal cases, assessing treatment efficacy
- Performed risk factor evaluations, identifying trends in neonatal sepsis management
- Utilized diagnostic methodologies, including blood cultures, CRP levels, and Procalcitonin biomarker analysis
- Provided data-driven clinical recommendations, optimizing neonatal sepsis treatment protocols
Education
Advanced Diploma - Clinical Research, Pharmacovigilance, Clinical Data Management, Regulatory Affairs, and Medical Writing
Learning Lab Research Institute (LLRI)
Bangalore09.2024
Doctor of Pharmacy (PharmD) -
Nirmala College of Pharmacy
Kadapa, AP01.2024
Skills
- Pharmacovigilance & Drug Safety
- Adverse event reporting (SAE/SUSAR)
- Regulatory guidelines (ICH, FDA, EMA, WHO compliance)
- Individual Case Safety Report (ICSR) processing
- Medical coding (MedDRA & WHODD)
- Causality assessment & listedness evaluation
- Data entry of safety data into adverse event tracking systems
- Data Accuracy & Query Resolution
- Patient narrative writing for case reports
- Expedited SAE/SUSAR report submission
- PSUR
- DSUR & expedited report preparation
- Periodic Safety Report (PSR) preparation
- Generating queries to resolve missing or discrepant data
- Clinical study reports & safety data abstraction
- Microsoft Office Suite (Word, Excel, PowerPoint)
- Attention to detail
- Time management
- Analytical Skills
- Team collaboration
- Effective communication
Certification
Advanced Diploma in Clinical Research
Timeline
Clinical Research and Pharmacovigilance Intern
Learning Lab Research Institute (LLRI)
04.2024 - 09.2024
Clinical Pharmacist Intern
Fathima Institute of Medical Sciences (FIMS)
06.2023 - 05.2024
Research Lead
Fathima Institute of Medical Sciences (FIMS)
10.2022 - 03.2023
Advanced Diploma - Clinical Research, Pharmacovigilance, Clinical Data Management, Regulatory Affairs, and Medical Writing
Learning Lab Research Institute (LLRI)
Doctor of Pharmacy (PharmD) -
Nirmala College of Pharmacy
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