Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Interests
SEMINARS / TRAININGS / WORKSHOPS
CO-CURRICULAR ACTIVITIES
Timeline
Generic
GRETA DAS

GRETA DAS

Vadodara

Summary

Gold Medalist in M.Pharm (Pharmacology) with a strong foundation in pharmacology, drug mechanisms, pharmacokinetics, and therapeutic strategies, complemented by 10 months of hands-on experience in clinical and regulatory documentation at Meril Life Sciences Pvt. Ltd. Proficient in preparing Clinical Study Reports (CSRs), patient narratives, and regulatory documents in strict adherence to ICH-GCP and ISO 14155 guidelines. Demonstrated expertise in safety data evaluation, event triggering processes, and the application of VARC, BARC, and ARC guidelines within medical device studies. Committed to advancing a career in Regulatory Affairs within the pharmaceutical industry while leveraging strong analytical and scientific writing skills developed through academic research and professional practice.

Overview

4
4
years of professional experience
2
2
Certifications
6
6
Languages

Work History

Clinical Regulatory Writer

Meril Life Sciences Pvt. Ltd.
05.2025 - Current
  • Collaborated with cross-functional teams to develop and align high-quality.
  • Clinical Study Reports (CSRs) are prepared in accordance with ICH E3, ICH-GCP (E6), and ISO 14155 guidelines.
  • Contributed to internal process optimization and timeline management through effective communication with stakeholders.
  • Worked extensively on clinical documentation and evidence generation for cardiovascular and structural heart medical devices.
  • Utilized reference management tools, such as EndNote, with a high level of proficiency to ensure accurate citation, bibliography formatting, and literature organization.
  • Used AI-driven tools and databases, such as PubMed and Google Scholar, to maintain regulatory-compliant literature and citation standards for CSRs.
  • Developed training modules, market study presentations, and study proposals aligned with strategic business goals.
  • Coordinated with clinical teams and external partners for documentation, communication, and project planning.

Siliguri District Hospital
01.2023 - 02.2023
  • During my hospital training, I gained practical experience in administering injections under supervision. I assisted in drug dispensing, ensuring accurate dosage and safe medication practices. I monitored patients for any reactions after injection and reported any side effects. Additionally, I provided patient education on proper medication usage and potential side effects, helping improve adherence.
  • Key Skills: Medical Documentation, Drug Dispensing, Patient Education, Injection Administration

Zuvendus Healthcare Limited
01.2022 - 02.2022
  • During my training, I observed key pharmaceutical processes such as applying SOPs, drug manufacturing practices, and clinical research procedures. I gained insight into quality control, pharmacovigilance, and drug dispensing, all while understanding the importance of maintaining regulatory compliance and patient safety. This exposure gave me a solid foundation in the practical aspects of the pharmaceutical industry.
  • Key Skills: Quality Assurance, Quality control, Pharmaceutical Manufacturing, SOP Handling, pharmaceutical Packaging

Education

M.Pharma - Pharmacology

Parul University
01-2025

Bachelor of pharmacy - Pharmacy (Full Time)

Himalayan Pharmacy Institute
Sikkim
01-2023

12th - WBCHSE

Siliguri Girls' High School
Siliguri
01-2019

10th - West Bengal Board Of Secondary Education

Siliguri Girls' High School
Siliguri
01-2017

Skills

  • Proficient in writing clinical study reports
  • Literature review
  • ICH-GCP, ISO-14155 compliance
  • Patient Narratives & Case Summaries

Accomplishments

  • Certificate of excellence for my performance in M.Pharm 1st semester for securing 2nd position
  • Certificate of excellence for my performance in M.Pharm 2nd semester for securing 1st position
  • Certificate of excellence for my performance in M.Pharm 3rd semester for securing 1st position
  • Certificate of excellence for my performance in M.Pharm 4th semester for securing 2nd position
  • Secured 2nd Position in Poster Presentation during ANRF Sponsored PicFOP-International Conference on "Frontiers in Drug Delivery Systems and Biopharmaceutics: Revolutionizing Medicine".
  • Certificate of excellence for my performance in M.Pharm for securing Highest SGPA
  • Awarded University Gold Medal in M.Pharm (Pharmacology) in recognition of outstanding academic performance.

Certification

Certificate of Completion – Training on Indian Medical Device Rules, 2017, organized by the Training and Development Department, Meril Academy, Vapi, Gujarat

Interests

Singing, Reading books, Gaming

SEMINARS / TRAININGS / WORKSHOPS

  • Frontiers in Drug Delivery Systems and Biopharmaceutics: Revolutionizing Medicine Institute Name: Faculty of Pharmacy, Parul University 24 Jan, 2025 - 25 Jan, 2025
  • Workshop on FRANZ DIFFUSION CELL during ANRF Sponsored PicFOP-International Conference on Frontiers in Drug Delivery Systems and Biopharmaceutics: Revolutionizing Medicine Institute Name: Parul University 23 Jan, 2025 - 23 Jan, 2025
  • One Day National Seminar on "Innovations in Immunotherapy: Monoclonal Antibodies and Vaccines in Modern Medicine" Institute Name: Parul University Key Skills: Presented Poster 14 Dec, 2024 - 14 Dec, 2024
  • Two days virtual international conference on "Recent Advances in Drug Development and Formulations" Institute Name: Sciquaint Innovations Attended this conference to learn about the latest trends in drug development and formulations. 22 Oct, 2024 - 23 Oct, 2024
  • Two days International conference on "Global Health Horizon: Empowering Pharmacists Through Research And Development" Institute Name: Indira Gandhi National Tribal University Key Skills: Actively participated in International Conference, Poster Presentation The initiative focused on providing insights into the latest advancements in pharmaceutical research, drug development, and healthcare solutions. 24 Sep, 2024 - 25 Sep, 2024
  • National Conference on "Pharma Symphony- Harmonizing Innovations in Science and Technology" Institute Name: Maharaja Sayajirao University of Baroda 14 Sep, 2024 - 14 Sep, 2024
  • One Day National Workshop on "Pharmaceutical Biostatistics: From Concept to Real world Applications" Institute Name: Parul University 31 Aug, 2024 - 31 Aug, 2024
  • One Day National Seminar Cum Poster Presentation "New Generation of Pharmacy: Sustainable and Personalized Care" Institute Name: Hon. Shri. Babanrao Pachpute Vichardhara Trust's Parikrama College of Engineering, Kashti 24 Apr, 2024 - 24 Aug, 2024
  • 58th SPSR Webinar on "AI tools for Scientific Writing & Publishing" Institute Name: Society of Pharmaceutical Sciences and Research in association with International Journal of Pharmaceutical Sciences and Research and International Journal of Pharmacognosy 28 Jul, 2024 - 28 Jul, 2024
  • One day Live Webinar on "Revolutionizing Clinical Research with Artificial Intelligence: Opportunities and Challenges" Institute Name: AIKTC-School of Pharmacy in association with Clinosil Research Private Limited 01 Jun, 2024 - 01 Jun, 2024
  • National Conference on Advancement and Challenges in Pharmaceutical Research and Industry Institute Name: Parul University 05 Apr, 2024 - 06 Apr, 2024
  • Hands on Training:Stereotaxic Surgery and Behavioural Testing for Preclinical Screening of CNS Disorders Institute Name: L.M. College of Pharmacy Key Skills: Stereotaxic Surgery and Behavioural Testing for Preclinical Screening of CNS Disorders Stereotaxic surgery precisely targets brain regions in animal models to study and manipulate specific neural circuits. Behavioral testing assesses the impact of these interventions on cognitive and motor functions, providing insights into central nervous system disorders. 16 Mar, 2024 - 16 Mar, 2024
  • NATIONAL SEMINAR ON "A HERBAL APPROACH TOWARDS ORGANIC MEDICINES" Institute Name: Himalayan Pharmacy Institute, Sikkim 24 Feb, 2023 - 25 Feb, 2023

CO-CURRICULAR ACTIVITIES

Science club, Debate

Timeline

Certificate of Completion – Training on Indian Medical Device Rules, 2017, organized by the Training and Development Department, Meril Academy, Vapi, Gujarat

07-2025

Certificate of Completion – Good Clinical Practice (GCP), six-hour course by NIDA Clinical Trials Network

05-2025

Clinical Regulatory Writer

Meril Life Sciences Pvt. Ltd.
05.2025 - Current

Siliguri District Hospital
01.2023 - 02.2023

Zuvendus Healthcare Limited
01.2022 - 02.2022

Bachelor of pharmacy - Pharmacy (Full Time)

Himalayan Pharmacy Institute

12th - WBCHSE

Siliguri Girls' High School

10th - West Bengal Board Of Secondary Education

Siliguri Girls' High School

M.Pharma - Pharmacology

Parul University
GRETA DAS