MD Pharmacology Consultant - Independent Practice - Vadodara, Gujarat, India
Independent MD Pharmacology Consultant providing clinical research, medical affairs, pharmacovigilance, clinical trial, BA/BE, Medical & scientific writing, and healthcare research support for pharmaceutical, CROs and medical device sectors. Ethics Committee Member, Anand Institutional Ethics Committee of Anand Multispeciality Hospital, Vadodara.
Head - Clinical Research and Medical Affairs - Advanced MedTech Solutions Pvt. Ltd.
(2025-09 - 2026-05)
- Developed and supported clinical research strategy for medical device programs including clinical investigations, post-market surveillance studies, registries, and real-world evidence initiatives.
- Contributed to ISO 14155, ICH-GCP, CDSCO, MDR/FDA-aligned documentation, clinical evaluation reports, technical documentation, and regulatory approval support.
- Managed CRO, investigator, ethics committee, hospital, and academic institution interactions while monitoring study timelines, data quality, budgets, and deliverables.
- Led medical affairs activities including scientific communication material, evidence summaries, publications, training content, medical response documents, KOL engagement, CMEs, and medical review of promotional material.
- Supported publication strategy, manuscript development, abstract preparation, clinical data interpretation, adverse event reporting, and risk-benefit assessment.
Clinical Head and Facility Incharge; Principal Investigator - Accutest Research Laboratories (India) Pvt. Ltd. - Vadodara
(2021-07 - 2025-09)
- Managed clinical systems, facility operations, and study execution for BA/BE, clinical endpoint, PK-PD, and clinical trial studies.
- Reviewed feasibility, protocols, ICFs, CRFs, SOPs, clinical reports, amendments, study documentation, and ethics committee submissions.
- Oversaw planning, conduct, monitoring, reporting, subject safety, pharmacy responsibilities, randomization/code-breaking procedures, data quality, and document retention.
- Performed AE/SAE assessment and reporting, acted as medical expert/medical monitor when required, and ensured protection of subject rights, safety, and welfare.
- Handled sponsor audits, regulatory inspections, IEC interactions, monitor queries, CAPA support, and inspection readiness activities.
Clinical Research Scientist; Principal Investigator - Watson Pharma Private Limited, A TEVA Company - Navi Mumbai
(2020-01 - 2021-06)
- Planned, conducted, monitored, and reported clinical studies while maintaining clinical systems and facility compliance.
- Prepared and reviewed protocols, informed consent forms, CRFs, SOPs, clinical reports, IEC submissions, and amendments.
- Managed investigational product accountability, protocol training, delegation of responsibilities, informed consent, screening, subject eligibility, subject safety, and AE/SAE reporting.
- Supported sponsor, QA, IEC, and regulatory audits by providing documentation, responses, and study conduct clarification.
Deputy Manager; Investigator / Research Physician - Alembic Pharmaceutical Pvt. Ltd. - Vadodara
(2017-02 - 2020-01)
- Supported clinical facility management, study planning, protocol and study document review, IEC communication, SOP preparation, clinical report review, and study timelines.
- Managed informed consent, screening, subject eligibility, clinical assessment, investigational product accountability, AE/SAE recording and reporting, and subject safety oversight.
- Participated in audit and inspection activities involving sponsors, QA, IEC, and regulatory agencies.
Tutor / Resident, Pharmacology - Government Medical College, Baroda
(2015-02 - 2017-02)
- Performed academic, teaching, administrative, and departmental responsibilities for medical education at Baroda Medical College.
