Vijaysinh Sindha
Vadodara
Summary
Dynamic professional with extensive experience in pharmacovigilance and medical affairs at WIPRO LTD. Proven expertise in regulatory submissions and staff training, complemented by strong analytical skills and effective communication. Recognized for enhancing safety protocols and mentoring teams, ensuring compliance with evolving regulations in clinical research.
Overview
8
8
years of professional experience
Work History
Assistant manager
WIPRO LTD
Pune
07.2024 - Current
- To perform medical review of cases according to Wipro and client specific SOPs and conventions
- Provides medical expertise in medical assessments of causality of cases
- Perform Quality review of completed or locked cases in safety database
- Contribution to safety and PV training program, development of SOPs and other guideline document
- To review and provide PV therapeutic area input for development of protocols, IBs if required
Drug Safety Physician
Apcer Life Sciences
Ahmedabad
01.2021 - 06.2024
- Manage daily workload in conjugation with line manager for individual case processing, literature searches, aggregate reports generation and any other tasks relevant to the Pharmacovigilance Department
- Medical Review of ICSR's in pharmacovigilance database and aggregate reports for expedited/periodic submission as per the Regulations and SOPs
- Handling of medical query/spontaneous ADR cases as per applicable SOP
- Generation and review of SOPs and WIs and execution of company SOPs
- Maintain awareness of changes to/new regulations affecting PVG activities
- Compliance to project guidelines
- Trains and mentors new employees in PVG (if required)
- To carry out necessary administrative duties required for the job
- Other duties as assigned by management
Manager in Medical Affairs and Pharmacovigilance
Veeda Clinical Research
Ahmedabad
10.2019 - 01.2021
- Review/Preparation of clinical trial documents for domestic and global regulatory submission (e.g
- Protocol Synopsis, Study Protocols, Investigator's Brochure, Informed consent forms, Case Report Forms, Clinical Study Reports, Patient Diaries, and Case Record Form etc.)
- Liaises with the study team, the Sponsor and the Key Opinion Leaders (KOLs) in therapeutic areas to finalize the study related documents
- Representative as a Medical Expert to regulatory/sponsor/study sites for various clinical studies
- Conducting the preliminary feasibility for the clinical trials as per the proposal from sponsor
- Review/Supervision of protocol synopsis & initial quotation prepared for feasibilities
- Review/Supervision of protocol preparation
- Protocol and therapeutic/technical training to the operation team of clinical trials
- To visit Investigator's site for site study personnel's training & medical monitoring
- Review of the screening reports, randomization request, SAE forms, safety data and various medical reports during the study conduct
- To ensure that safety information received from the site and the sponsor is processed consistently, accurately, in a timely manner and in compliance with GCP/protocol/SOPs/Schedule Y and reported to regulatory authority
- To perform SAE reconciliation
- Preparation/Review of Safety Management & Medical Monitoring Plan
- Review of clinical study reports and to provide inputs related to medical aspect
- Review & Preparation of safety documents (AE logs, SAE & Pregnancy forms)
- Keep abreast with the development in the field of clinical research in India and overseas
Principal Investigator
Accutest Research Laboratories
Vadodara
08.2017 - 10.2019
- To review feasibility of proposed BA/BE (Bioavailability/Bioequivalence) study
- To review and approve protocol of the BA/BE study under consideration
- To discuss with the analytical investigator about the methodology required for the estimation of the said(s) under consideration
- To provide BA/BE protocol, informed consent form, reference literature and other written information to be provided to subjects (if applicable) to the IRB/IEC
- To arrange for the ethics committee (EC) meeting and procure the approval of the EC for the conduction of the proposed BA/BE study
- To organize by making necessary arrangements for the conduction of the said BA/BE study in coordination with ARL-CPU staff members
- To check the compliance of the approved protocol during conduction of the BA/BE study
- To ensure that any amendment to the protocol has been approved by sponsor, IRB/IEC and regulatory authority (ies), if required
- To prepare and review the standard operating procedures (SOPs)
- To provide protocol and SOP training to all staff members involved in conduction of the study
- To ensure that any deviation observed during conduction of the study is documented and evaluate the deviation and take corrective and preventive action
- To follow the randomization and code breaking procedure (if any)
- To ensure that all the study subjects have signed and dated the informed consent before participation in the study
Education
MD - PHARMACOLOGY
B. J. Medical College
Ahmedabad, Gujarat07.2017
M.B.B.S. -
B. J. Medical College
Ahmedabad, Gujarat03.2012
HIGHER SECONDARY -
I.P.C.L School
Vadodara03.2007
Skills
- Communication and presentation
- Team work
- Analytical skill
- MS Office
- Literature search
- Time management
- Staff training and development
- Multitasking and organization
Research Publications
- A comparative evaluation of drugs used in Gastro Esophageal Reflux Disease.
- Article published: Entitled 'Antidiabetic and Hypolipidemic effects of extracts of Gymnema Sylvestre in Streptozotocin Induced Type 1 Diabetes in rats' in The Indian Journal of Veterinary Science & Biotechnology.
- Oral paper presentation on 'A comparative evaluation of drugs used in Gastro Esophageal Reflux Disease' at 48th Annual Conference of Indian Pharmacological Society IPSCON on 12/19/15.
- Poster Presentation on 'A comparative evaluation of drugs used in Gastro Esophageal Reflux Disease' C.M.E programme on 'resident doctors as front line medical teacher', 09/01/16.
Conferences Courses Attended
- National workshop on Research Methodology and Scientific Writing at U.N. Mehta Institute of Cardiology and Research Centre in 10/01/14.
- National workshop on Clinical Pharmacology and Therapeutic: NWCPT-2015 at PGI Chandigarh.
- Preconference workshop on Good clinical practice and Bioethics at IPSCON-2015 held in Saurashtra University, Rajkot, Gujarat.
- Conference of Indian Pharmacological Society: IPSCON-2015 at Saurashtra University, Rajkot, Gujarat.
- The art of scientific writing and presentation skills, 09/01/15 by Ahmedabad Obstetrics And Gynaecological Society.
- Workshop on 'Good clinical practice' organized by Institutional ethics committee, B J Medical College and Civil Hospital, Ahmedabad, 01/01/16.
- C.M.E programme on 'resident doctors as front line medical teacher', 09/01/16 at AMCMET Medical College.
- Workshop on 'Advance level training on Pharmacovigilance', organized by B J Medical College collaboration with NCC-PvPI, 01/01/17.
Languages
- English
- Hindi
- Gujarati
References
- Dr. Manish N Solanki, Associate professor, Department of Pharmacology, BJMC, Ahmedabad, M-9428826729
- Dr. Chetna K. Desai, Professor, Department of Pharmacology, BJMC, Ahmedabad, M-9904011644
Disclaimer
I, the undersigned, hereby testify that the above said information is true to the best of my knowledge and belief.
Areas Of Interest
- Clinical Pharmacology
- Pharmacovigilance
- Medico-marketing
Personal Information
- Father's Name: Sindha Vikramsinh Takhatsinh
- Date of Birth: 01/21/90
- Marital Status: Married
Timeline
Assistant manager
WIPRO LTD
07.2024 - Current
Drug Safety Physician
Apcer Life Sciences
01.2021 - 06.2024
Manager in Medical Affairs and Pharmacovigilance
Veeda Clinical Research
10.2019 - 01.2021
Principal Investigator
Accutest Research Laboratories
08.2017 - 10.2019
MD - PHARMACOLOGY
B. J. Medical College
M.B.B.S. -
B. J. Medical College
HIGHER SECONDARY -
I.P.C.L School
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