Months of professional experienence
Dr. DIVITH H
Bangalore
Summary
Enthusiastic and motivated Pharm D graduate with a Doctoral degree in pharmacy, professionally certified in Clinical Research, Pharmacovigilance and Regulatory affairs. Eager to leverage my academic background and internship experience to contribute effectively to the healthcare sector
Overview
4
4
1
1
Certification
1
1
Year fellowship as part of fellowship
Work History
regulations intern
Brainsightai
bangalore, karnataka
07.2025 - 10.2025
- Implementation of ISO 13485 (QMS) for SAMD, while focusing on a risk management system ISO 14971 and information security management system (ISMS).
- RCA for CAPA
- Indepth Knowledge with EU MDR (2017/745) and US FDA 21 CFR 11 and 820.
- Worked on Drafting SOP and getting it validated with the Team lead.
- Vendor evaluation and Engineering change request validation.
- Progress management using jira board and maintaining a high degree of interoperability between the various teams.
Monitoring the new sprint release for all the latest changes. - Taking part in the MRM, and getting insights on the requirements of the management.
- worked on a poster titled "AI/LLMs in Risk Management" with the entire team which was presented in TOPRA, Berlin 2025
clinical pharmacist
Basaveshwara medical hospital (BMCH)
chitradurga
12.2023 - 12.2024
- Worked as a clinical pharmacist in Basaveshwara medical hospital (BMCH) for 1 year
- Provided patient counseling on medication usage, adherence, and lifestyle changes.
- Actively and passively participated in ward rounds, collaborated with healthcare team to discuss treatment plans and optimize patient care.
Education
DOCTOR OF PHARMACY - Pharmacy
Shri Jagadguru Murugarajendra College of Pharmacy
Chitradurga12-2024
Intermediate -
Vagdevi PU College
Udupi01.2018
Matriculation -
Vidyanikethan Public School
Kapu01.2016
Skills
Regulatory Affairs
- knowledge of regulatory submissions and dossiers: IND, NDA, ANDA, MAA, BLA and CTD
- knowledge of Drug master file and its importance
- Knowledge of medical device registration process: CE marking, 510k PMA
Pharmacovigilance
- Exposure to reporting systems: spontaneous reporting, MedWatch, Yellow card, and blue card
- Familiarity with ICSR workflow and MedDRA coding
- Knowledge of Causality assessment methods: WHO-UMC, Naranjo scale and bradford scale
- Proficient with microsoft office suite
Management skills
- Task delegation
- Strategic thinking
- Time management
- Conflict resolution
Certification
Certification Course - Orange Innovations ISO Certified Training Institute: 3-month advanced certification course on the basic concepts in Clinical Research, Clinical Data Management, Pharmacovigilance and Regulatory Affairs.
Projects
TITLE: "Life style pattern, psychological health, physiological activities and it's impact on daily performance of degree scholars in Chitradurga city", Objective: To evaluate the distribution of similar life style characteristics in students and assess the correlation between lifestyle pattern psychological and physiological activity on daily performance in degree school students., Methods: descriptive analytical study ., Conclusion: The findings revealed direct correlation between poor lifestyle choices and academic struggles, physiologically sound participants add a higher proportion of individuals achieving average and good academic performance. this indicates a confluence in the parameters which grossly impact the academic performance.
Timeline
regulations intern
Brainsightai
07.2025 - 10.2025
clinical pharmacist
Basaveshwara medical hospital (BMCH)
12.2023 - 12.2024
DOCTOR OF PHARMACY - Pharmacy
Shri Jagadguru Murugarajendra College of Pharmacy
Intermediate -
Vagdevi PU College
Matriculation -
Vidyanikethan Public School