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Dikshya Thakuri

@dikshyathakuri

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Pharmaceutical professional specializing in BA/BE, clinical research, bioanalysis.

India

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What I'm looking for

I am seeking a role in a reputed BA/BE or clinical research center where I can ensure regulatory compliance, drive high-quality bioanalytical deliverables, and grow professionally within a collaborative, process-driven team.

I am a results-driven pharmaceutical professional with hands-on experience in Bioavailability/Bioequivalence (BA/BE) studies, clinical research, bioanalytical R&D, pharmacovigilance and quality assurance. I have contributed to study audits, eCTD compilations and regulatory submissions while ensuring compliance with international guidelines.

I have worked as a Research Associate in Clinical Research and as a Drug Safety Associate, delivering CAPA and change-control activities, MedDRA-coded safety narratives, and validated bioanalytical method reports. I combine technical expertise (eCTD, SDMS, IXLC spreadsheets) with clear communication and collaborative teamwork to improve operational quality and timely regulatory delivery.

Experience

Work history, roles, and key accomplishments

Research Associate

Micro Labs Limited

Feb 2023 - Aug 2025 (2 years 6 months)

Conducted clinical research and BA/BE study activities, performed audits of in-house and CRO study processes, and prepared bioanalytical and method validation reports to ensure regulatory compliance.

Clinical Research BA BE Auditing ECTD Compilation Medical Writing

Drug Safety Associate

Wipro

Jan 2021 - May 2022 (1 year 4 months)

Managed pharmacovigilance activities including adverse event reporting to regulators (USFDA, AEMPS, BfArM), MedDRA coding, and narrative writing to maintain safety compliance.

Pharmacovigilance Adverse Events MedDRA Narrative Writing Regulatory Submissions Communication

Pharmacist

Meena Medical Hall

Aug 2018 - Nov 2019 (1 year 3 months)

Provided pharmacy services including dispensing, patient counseling, and medication management to support community healthcare operations.

Dispenser Patient Counseling Medication Management Inventory Control Customer Service

Education

Degrees, certifications, and relevant coursework

MAKAUT University

Bachelor of Pharmacy, Pharmacy

Activities and societies: Investigational project on pathophysiology of asthma; phytochemical screening and in-vitro pharmacological studies on Michelia champaca; industrial training at Glenmark Pharmaceutical Ltd.; hospital pharmacist training at Birpara State General Hospital.

Completed Bachelor of Pharmacy from Bengal School of Technology affiliated to MAKAUT University, focusing on pharmaceutics and pharmaceutical sciences.