Publications |process qa| Scientific writing | Pharmacovigilance | sops| journal articles | primary and secondary Research | Training | project coordination| client liaison | professional women enthusiast worked in 3 countries (germany, uk, and india) and 3 domains (scientific Research and Teaching, Scientific writing, and Quality Assurance). work in close liaison with global companies. ability to work both in academic and corporate set-up with multicultural and Multilingual environment. broad understanding of scientific Research and writing . developed strategies and established Quality Assurance processes for Scientific writing and Regulatory Affairs- aggregate safety reports (pv), medical information, and label documents. Compliance monitoring, creating and reviewing capas, effectiveness check of capas, qmps, sops. project coordination of pv project, managed medical information project for global Healthcare companies. authored and reviewed manuscripts for peer reviewed journals, label documents for global pharma involved in Training of Scientific writing and Regulatory Affairs and qa team post doctoral Research in structural Analysis of new materials using esr Spectroscopy. Analytical Chemistry, and Biophysics. phd in natural Sciences (Biophysics/chemistry)- esr Spectroscopy, DNA irradiation Medical Writer certification from european medical writers association (emwa) 10+ years experience in Scientific writing and have published in peer-reviewed journals. Expert in primary and secondary Research. in-depth Research and Analysis skills for complex scientific projects, presentation and management, Expert in summarizing other scientific articles and reports, strategic literature search, Project Management, strong Communication Skills, partnered with global pharma icons, strong Problem Solving attitude, fast learning capability, and aptitude for Teaching/Training . love to explore new fields, Research and Analysis and Training.
Since December 2015
Lead Quality Specialist I- Scientific Writing and Regulatory AffairsJanuary 2014 --- November 2015
scientific affairs quality and Compliance monitoring audit support benchmarking best practices process improvement across projects promote 'right first time' mindset in the department Quality Assurance of safety aggregate reports, medical information responses, label documents and other projects related to Scientific writing and Regulatory Affairs project coordination and management. support the department for Change Control, non-conformities, SOP review and SOP writing, templates, preparing standard checklists, Quality Management plans, guidance docuemtns etc strong engagement with client ensure audit/inspection preparedness of the department expertise in Root Cause Analysis, reviewing capa Training team members from Scientific writing on Quality Management systems, on key sops
Coordinator, Quality Assurance -Scientific Writing and Regulatory AffairsJanuary 2013 --- December 2013
quality analysis of ongoing projects in Scientific writing and Regulatory Affairs. preparation of sops, project coordination and Data Analysis for Pharmacovigilance projects. Training, audit support. written articles on Medical writing for international journals. Communication with client.
Medical WriterJuly 2011 --- December 2012
specialized in medical information inquiries for emerging markets, Publications for peer-reviewed journals (manuscripts, abstracts, and posters), and other regulatory documents. experience of working in cross-cultural and across different time zones in strong liaison with global Pharmaceutical company. experience in Document Management and Data Management system. Training new team members on handling medical information inquiries, manuscript writing, csr to manuscript writing .
Freelance writerNovember 2010 --- June 2011
writing for emwa, writing manuscript, abstracts, summarizing peer reviewed articles, reviewing manuscripts, writing about alternative science careers
LinkedIn Assessment :
PhD in Natural Sciences, Chemistry, Biophysics from Universität des Saarlandes in 2007
Post M.Sc. in Bio-physics from Saha Institute of Nuclear Physics, Kolkata, India in 2000
M.Sc. in Chemistry from Visva-Bharati in 1999
B.Sc in Chemistry from Visva-Bharati in 1997
Class 12, Suratgarh, Rajasthan in Sciences from Kendriya Vidyalaya in 1994
Class X, Port Blair, Andaman and Nicobar Islands in Maths, English, General Sciences, Social Studies, Hindi from Kendriya Vidyalaya in 1992
Training and Certification
Foundation Certificate in Medical Writing in 0000 Certification
Area / Region
Bengaluru, Karnataka, India