Dr Hiral Vasava
Ahmedabad
Summary
To work and contribute in the field of Clinical Research- Bioavailability and Bioequivalence studies, Clinical Trials and Pharmacovigilance.
Overview
1
1
Certification
11
11
years of professional experience
Work History
Medical Monitor
Lambda Therapeutics Research
Ahmedabad
06.2025 - Current
- Monitored patient safety data during clinical trials to ensure ethical standards.
- Evaluated adverse events, serious adverse events and other safety data from clinical trials.
- Analyzed adverse event reports to identify trends and potential risks.
- Conducted site visits to evaluate trial progress and adherence to protocols.
- Developed monitoring plans and performed on-site visits for clinical trials.
- Drafted clinical trial protocols ensuring adherence to regulatory standards.
- Performed literature searches to identify relevant safety issues related to the trial drug.
Principal Investigator/ Manager
Cadila Pharmaceuticals Ltd
08.2023 - 06.2025
- Executed the planning, conducting, supervising, and reporting of BA/BE studies in compliance with protocol, SOPs, and regulatory standards.
- Assessed the feasibility of investigational products and protocols by conducting thorough evaluations of their requirements and potential challenges.
- Monitored safety data and reported findings on adverse events to ensure compliance with regulatory guidelines.
- Assessed causality, seriousness, and expectedness of SAEs by reviewing SAE forms and related documents during clinical study.
- Conducted medical monitoring for clinical trials and site monitoring visits.
- Reporting of AE/ SAE to Pharmacovigilance Department and supporting in Periodic adverse drug experience report.
- Review of Protocols, Informed Consent forms and Case report forms.
Principal Investigator/ Deputy Manager
Vayam Research Solutions Ltd.
12.2022 - 08.2023
- Maintained compliance with ethical guidelines, ensuring responsible conduct of research activities throughout all stages of project lifecycles.
- Supervised screening, recruitment, and eligibility evaluation of volunteers for clinical studies, ensuring alignment with study protocols.
- Review of Investigator’s Brochure and literature.
- Reviewed study protocols, informed consent forms, case report forms, and prepared standard operating procedures to uphold regulatory compliance.
- Managed adverse and serious adverse events through monitoring and reporting to maintain participant safety and integrity of study data.
- Ensuring and monitoring safety of volunteers participating in BA/ BE studies.
Medical Officer
HDA Clinic
04.2022 - 11.2022
- Monitored patient progress, adjusting treatments to enhance recovery and well-being.
- Improved patient outcomes by implementing evidence-based medical practices and protocols.
- Improved patient outcomes and delivery of care through improved clinical quality processes.
- Conducted rounds to perform comprehensive medical examinations for indoor and outdoor patients, ensuring thorough evaluations.
Resident Medical Officer
Chandan Neuroscience Hospital
10.2019 - 10.2021
- Functioned as a resident doctor in the clinical radiology department, contributing to patient care and departmental operations.
- Collected information about patient histories, current conditions and vital statistics to make accurate determinations about conditions.
- Prevented medical errors through vigilant attention to detail and strict adherence to established guidelines.
- Educated patients on procedures, conditions, and medications to enhance understanding and promote compliance.
- Delivered on-call support for urgent situations, effectively addressing emergencies to ensure patient safety.
Principal Investigator/ Co-Investigator/ Physician
Veeda Clinical Research Pvt Ltd
11.2015 - 11.2018
- Led clinical research studies as principal investigator, ensuring adherence to protocols and regulatory standards.
- Planned, conducted, and supervised the BA/BE and PK studies in accordance with protocol, SOP, and regulatory requirements.
- Monitored and ensured safety of volunteer participation in clinical studies, fostering a secure research environment.
- Managed handling and reporting of adverse events and serious adverse events, contributing to patient safety and protocol compliance.
Medical Officer
HCG Cancer Center
05.2015 - 08.2015
- Monitored chemotherapy procedures and managed adverse events to ensure patient safety and effective treatment.
- Conducted medical examinations of patients, documenting clinical findings to inform treatment plans.
- Prepared indoor and outdoor patient files, coordinating discharge procedures to ensure smooth transitions for patients.
Education
Internship 2014
BJ Medical College
Ahmedabad01-2014
Foreign Medical Graduate Examination - Medicine
Medical Council Of India
New Delhi04-2013
MBBS - Medicine
Bukovinian State Medical University
Ukraine05-2012
Skills
- Clinical trial monitoring
- Regulatory compliance
- Adverse event reporting
- Risk assessment
- Data analysis
- Study management and research
- Attention to detail
- Observational skills
- Team and individual efficiency
Certification
- Good Clinical Practice, GCP- NIDA CTN
- Good Clinical Practice
- ACLS- BLS training
- Seminar on Advance ECG- Rhythm 2017
- Certificate course in Pharmacovigilance practical ICSR
Personal Information
Title: Principal Investigator/Medical Monitor/ Clinical Research
Drhiral2012@gmail.com
Certifications
12-2022
Timeline
Medical Monitor
Lambda Therapeutics Research
06.2025 - Current
Principal Investigator/ Manager
Cadila Pharmaceuticals Ltd
08.2023 - 06.2025
Principal Investigator/ Deputy Manager
Vayam Research Solutions Ltd.
12.2022 - 08.2023
Medical Officer
HDA Clinic
04.2022 - 11.2022
Resident Medical Officer
Chandan Neuroscience Hospital
10.2019 - 10.2021
Principal Investigator/ Co-Investigator/ Physician
Veeda Clinical Research Pvt Ltd
11.2015 - 11.2018
Medical Officer
HCG Cancer Center
05.2015 - 08.2015
Internship 2014
BJ Medical College
Foreign Medical Graduate Examination - Medicine
Medical Council Of India
MBBS - Medicine
Bukovinian State Medical University