Dr Kuval H J
Bengaluru
Summary
Dynamic clinical researcher with extensive experience at Syngene International Limited, excelling in pharmacovigilance and regulatory compliance. Proven track record in managing complex studies and ensuring anytime audit readiness. Skilled in Kaizen, root cause analysis and SOP development, fostering team collaboration to achieve project goals efficiently.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Principal Investigator
Syngene International Limited
Bengaluru
08.2022 - Current
- Conducted research (BA/BE, Phase 1) as a clinical investigator in compliance with ICH-GCP and relevant regulatory guidelines, per protocol (25+ clinical studies).
- Overall conduct of the clinical part of the study, including pre-study screening of volunteers, assessment of eligibility criteria, medical care, and adverse drug reaction (ADR) monitoring, as well as management of adverse events (AEs) and serious adverse events (SAEs), including post-study safety evaluation.
- Actively arranged and participated in team/sponsor meetings to discuss project status updates, or issues that arose during a study's duration.
- Supervised development of protocols and CSR to ensure adherence to regulatory standards, and sponsor requirements.
- Review of the Investigator's brochure, ICD, protocol amendments, EC documents, CRF, IMP document, and regulatory approval letters.
- As an audit facing SMEs for numerous regulatory inspections (USFDA, ANVISA, EMA, MHRA, CDSCO) and internal quality audits, everyday audit readiness was ensured.
- Undertook SOPs development, review, effectiveness check, staff training, and periodic revision.
- As a Track-wise application user, I handled deviations from investigation, root cause analysis, impact assessment, until the CAPA proposal, CAPA implementation, and CAPA effectiveness check.
- Performed periodic quality checks of the facility as a part of GEMBA walk.
Project Manager and Healthcare Advisor
Udhaivi Healthcare India Private limited
Bengaluru
02.2022 - 05.2022
- Management of multiple healthcare plans (community, corporate, school) with competing deadlines simultaneously.
- Training of the sales team, and reporting of progress to the internal project team and stakeholders.
- Managed project expenditures in accordance with the allocated budgets.
Medical Officer
Navachetana Hospital
Bengaluru
10.2021 - 01.2022
- Conducted physical examinations of patients and documented findings in patient records. Based on diagnosis and individual needs, evaluated test results, and implemented treatment plans for patients.
- Oversee the patients in the ICU, emergency ward, and in-patient wards.
- Performed minor surgical procedures and emergency medical procedures as per protocols.
PHC Medical Officer
Government of Karnataka
Arkalgud, Hassan
07.2020 - 07.2021
- Performed OPD for the rural population on a daily basis.
- Effectively implemented all national health programs at the PHC level.
- Training and supervision of ASHAs, ANMs, and health inspectors.
Education
MBBS - Medicine
MIMS
Mandya02-2020
Digital Health And Machine Learning - Grade A
IISC
Bengaluru12-2022
Skills
- Clinical research
- Pharmacovigilance
- Regulatory compliance
- Kaizen, root cause analysis, GEMBA
- Track-wise and SOPs development
- MS Excel, Fast typing
Languages
English
Advanced (C1)
C1
Kannada
Proficient (C2)
C2
Hindi
Intermediate (B1)
B1
Telugu
Beginner
A1
Affiliations
- Physical fitness
Accomplishments
2019 JDA (Junior Doctors Association) Secretary at MIMS Mandya
Certification
- IISC Digital Health (AI and ML) - Grade A
Timeline
Principal Investigator
Syngene International Limited
08.2022 - Current
Project Manager and Healthcare Advisor
Udhaivi Healthcare India Private limited
02.2022 - 05.2022
Medical Officer
Navachetana Hospital
10.2021 - 01.2022
PHC Medical Officer
Government of Karnataka
07.2020 - 07.2021
MBBS - Medicine
MIMS
Digital Health And Machine Learning - Grade A
IISC
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