Priyodarshi Sengupta
Kolkata
Summary
To work in an environment where there will be a scope for proving my abilities, skills and talent acquired over years of working in both biomedical and clinical research field. To be able to upgrade my skills in my relevant field and use them for professional growth and company goals. Experience in training, and handling team work and adhering to timelines. Self-motivating, hard-working and extremely articulate in English, Hindi, Bengali and elementary French.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Senior Regulatory Medical Writer
HCL Tech
Chennai
10.2022 - Current
- Job responsibilities include writing clinical evaluation report (CER), post-market follow up clinical evaluation report (PMCFER), and supporting writers to draft clinical plans (PMCFP and CEP) for medical devices
- Review of scientific and clinical literature, clinical trials, clinical studies grading and their summarization in the CER
- Analyzing and writing non clinical studies involving animal studies, toxicology and immunological assay reports, usability studies, design verification and validation studies
- Knowledge about literature search, and appraisal of clinical data from different literature databases like Cochrane, Google Scholar, Embase, PubMed, and different guidelines and recommendations
- Ensuring quality by following internal and external SOPs, work Instructions and forms/templates for successful preparation of robust clinical documents
- Assisting stakeholders and conduct deliverable initiation meetings and weekly meetings with clients to follow-up on specific tasks and projects
- Helping clients for preparing documents related to the safety and performance claims, objectives and clinical benefits and their acceptance criteria for the medical device
- Skilled at using like MS word, PowerPoint and Excel and writing tools like PerfectIt, Grammarly and Endnote referencing manager
- Project management skills like ability to work independently, timely delivery of CERs, and meeting deadlines and stakeholder's commitments, Handling projects at a time and delivering them to clients on time with robust quality
Medical Writer
Clirnet Services Limited
Kolkata
06.2022 - 10.2022
- Company Overview: India's largest doctor platform
- Worked with the research and editorial team at Clirnet Services Limited, Kolkata which is India's largest doctor platform as a medical writer
- Responsibilities involved review of clinical literature, drafting and writing various medical topics, using latest clinical guidelines (like NICE, ESC, ACOG, ASH, ICMR etc) clinical trial reports, meta-analysis studies and reviews on different clinical and surgical topics using different databases like PubMed, Cochrane, New England Journal of Medicine, Lancet etc
- Other responsibilities involved editing of different clinical topics from medical transcripts and seminars
- A competent user in Microsoft Word and Excel
- India's largest doctor platform
Research Fellow
Department of Regenerative Medicine and Translational Science, School of Tropical Medicine
Kolkata
09.2018 - 05.2022
- Conduct and assist PI and other clinicians in clinical trials and clinical research related to the application of Regenerative Medicine in patients at the Medical College and Hospitals
- Duties that included were helping the PI intaking informed consent from the patient, writing patient source document at the time of visit and filling out health questionnaires
- Report PI in case of any adverse event
- Actively participated in in vitro laboratory works related to stem cell biology
- Expert in human and rat mesenchymal, and embryonic stem cell lines (WiCell lines) and from primary sources like fat adipose tissue, amniotic fluid and amniotic membrane
- Knowledge on characterization studies using immunocytochemistry studies, Flow Cytometry, and Western Blotting
- Working knowledge on Fluorescence and Confocal microscopy, animal studies and Isolation of human cord blood cells from mononuclear cells
- Involved in the preparation and writing of different scientific and clinical manuscripts for different peer reviewed journals
- Also authored some chapters with Springer Nature and Intech Open on different clinical topics related to human physiology, surgery and regenerative medicine
- Was actively involved in teaching fellowship and M.Phil
- Students at the Department of Regenerative Medicine and Translational Science, School of Tropical Medicine
Clinical Research Coordinator
Clinovation Research Private Limited
06.2012 - 10.2013
- Was responsible for overseeing four clinical trials pertaining to diabetes and chest medicine
- Supervised clinical trials pertaining to drug discovery and development of new molecular entity (NME) for diabetes, SGLT2 class inhibitors, Empagliflozin
- Also supervised a statistical study of Asia Pacific Burden of Respiratory Disease, APBORD
- Trained on patient ICF, documentation of trial study specific reports like CRFs, RDC (Remote Data Capture) study specific patient visits, coordination with clinical laboratories, institutional ethics committee, interaction with sponsor and regulatory authorities for SAE and AE reports, ICH-GCP, Remote Data System (RDS) and Sponsor + USFDA initiated clinical trial audits
Education
M.Phil. - Regenerative Medicine and Translational Science
Calcutta School of Tropical Medicine & The West Bengal University of Health Sciences
Kolkata01.2016
Post graduate diploma - Clinical Research and Trials management
Cliniminds India Pvt. Ltd
Kolkata01.2012
M.Sc. - Stem Cell & Regenerative Medicine
The University of Sheffield
Sheffield, United Kingdom01.2008
B.Sc. - Biotechnology
Peoples Educations Society, Degree College, Bangalore University
Bangalore01.2007
Skills
- Medical and Scientific writer
- Clinical Research
- Proficient in MS Word
- Proficient in MS Excel
- Proficient in MS PowerPoint
- Literature review
- Regulatory writing
- Content writing
- Writing tools
- EndNote Citation manager
- PerfectIT
- Grammarly
- Biomedical science
- Clinical trials
- Stem cell
- Scientific and medical content writing
- Regulatory writing
- Clinical evaluation report and plan writing
- Post Market Clinical evaluation writing
Certification
- Online certification course in the science of stem cells, American Museum of National History, New York, U.S.A., 2022
- Online certification course program on Drug Discovery, University of California San Diego and Coursera, U.S.A., 2022
- A month online certificate course, BioLim, Centre for Science and Technology, Chennai, India, 2022
- Online certification attendance, Uedmy, Transplantation Immunology, Cell Therapy for Covid19, 2022
- Online course certification and hands on experience, Biotecnika, India, Advance Cell Culture Techniques, 2022
- An introduction to good laboratory practice, Indian Institute of Technology-Guwahati, 2022
- Basics and trouble shooting of Flow Cytometry, Abcam Inc., USA, 2021
- Scientific Writing in Health Research, Indian Council of Medical Research (ICMR), 2022
- Good Clinical Practice (GCP), Novo Nordisk India, 2013
- Advance diploma in Tissue engineering and biomaterials, Indian Institute of Technology-Chennai and Alison online education platform, 2022
Accomplishments
- Secured the first rank, and gold medal (first class first) in M.Phil. Regenerative Medicine and Translational Science, The West Bengal University of Health Sciences.
- Secured an overall rank of 'B' in All India Science Talent Examination, 2000.
- Secured the highest marks in molecular biology and zoology in Semester IV during B.Sc. program.
- Represented India Oil Corporation in junior club cricket in 2001.
- Competent in English language with the last academic IELTS score 7.0 with no band less than 7.0. Recently received a score of 520, graded as C1 advanced in core English skills by British Council.
- Have authored book chapters with leading publication houses like Springer Nature and InTechOpen.
- Have published more than 8 articles in different journals.
Languages
- English, C1 Advanced
- Hindi, C1 Advanced
- Bengali, C2 Proficient
- French, A1 Beginner
Hobbies and Interests
- Animal care and pet
- Cooking
- Football
- Astronomy and astrophysics
Custom Section
- Clinical research
- Biomedical science
- Clinical trials and management
- Stem cell
- Scientific and medical writing
Personal Information
- Age: 39
- Date of Birth: 10/27/85
- Marital Status: Married
Languages
Hindi, Bengali
First Language
English
Advanced
C1
Timeline
Senior Regulatory Medical Writer
HCL Tech
10.2022 - Current
Medical Writer
Clirnet Services Limited
06.2022 - 10.2022
Research Fellow
Department of Regenerative Medicine and Translational Science, School of Tropical Medicine
09.2018 - 05.2022
Clinical Research Coordinator
Clinovation Research Private Limited
06.2012 - 10.2013
M.Phil. - Regenerative Medicine and Translational Science
Calcutta School of Tropical Medicine & The West Bengal University of Health Sciences
Post graduate diploma - Clinical Research and Trials management
Cliniminds India Pvt. Ltd
M.Sc. - Stem Cell & Regenerative Medicine
The University of Sheffield
B.Sc. - Biotechnology
Peoples Educations Society, Degree College, Bangalore University