NAVYA SARA SANTHOSH
Carlow,Ireland
Summary
MSc candidate in Pharmaceutical Regulatory Affairs at SETU, Ireland, with a Doctor of Pharmacy degree and strong background in quality control, pharmacovigilance, and regulatory compliance. Experienced in data analysis, laboratory audits, GMP documentation, and adverse event reporting. Proven ability to adapt quickly, work effectively in cross-functional teams, and uphold the highest standards of quality and ethics. Skilled in ICH, FDA, EMA, and HPRA guidelines.
Core Competencies
Quality Control & GMP Compliance, Data Validation, Regulatory Guidelines (EMA, FDA, ICH, HPRA), Pharmacovigilance & Risk Assessment, Documentation (SOPs, TMs, IQ/OQ/PQ Protocols), Team Collaboration & Communication, In-process Control Testing, Clinical Data Abstraction & Analysis, Microsoft Office, Electronic Data Systems, Calibration, & Troubleshooting
Overview
2
2
years of professional experience
1
1
Certification
Work History
Data Analyst
Symphony Concerto India Private Limited
Bengaluru, India
01.2024 - 05.2024
- Reviewed medical records via electronic data systems for data abstraction.
- Extracted and validated clinical data for regulatory and project submissions.
- Responded to abstractor queries and supported quality checks for project deliverables.
- Gained experience in handling technical data in alignment with clinical guidelines.
Pharm.D Intern
Aster CMI Hospital
Bengaluru, India
10.2022 - 10.2023
- Conducted audits as per NABH standards.
- Performed prescription review, patient counselling, and high-risk drug administration monitoring.
- Participated in antimicrobial stewardship and pharmacovigilance (ADR & interaction reporting).
- Developed recommendations based on medication trend analysis and clinical evidence.
- Collaborated with interdisciplinary teams to maintain documentation and SOP compliance.
Education
Master of Science - Pharmaceutical Regulatory Affairs
SETU
Carlow, County Carlow 09.2024 -
Doctor of pharmacy degree - Pharmacy
KLE University
08.2017 - 10.2023
Skills
- Analytical & Critical Thinking
- Attention to Detail
- Time Management
- SOP & Protocol Writing
- Quick Learner
- Ethical Conduct & Team Collaboration
- Digital Skills: MS Office, EHR Platforms
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Academic Projects
- Pharmacovigilance in Europe: current regulatory obstacles in the pharmaceutical sector and strategies for addressing them (ONGOING)
- RCT on L-Carnitine’s Effect on Anemia in Hemodialysis Patients
- Case Report: Hungry Bone Syndrome
- Case Study: Levofloxacin-Induced Hypoglycemia
Certification
CITI Good Clinical Practice Course for Clinical Trials Involving Drugs (ICH focus)
- GCP - Trials with Investigational Drugs & Biologics
CITI Health Information Privacy and Security (HIPS)
- Health information privacy and security
References
References available upon request.
Timeline
Master of Science - Pharmaceutical Regulatory Affairs
SETU
09.2024 -
Data Analyst
Symphony Concerto India Private Limited
01.2024 - 05.2024
Pharm.D Intern
Aster CMI Hospital
10.2022 - 10.2023
Doctor of pharmacy degree - Pharmacy
KLE University
08.2017 - 10.2023
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