I am a licensed dentist (BDS) with a clinical background who has transitioned into medical writing, clinical research, and pharmacovigilance. Over the past year, I have independently built a ten-project scientific and regulatory writing portfolio, encompassing drug monographs, systematic literature reviews, pharmacovigilance safety narratives, regulatory appraisals, and pricing and reimbursement strategy briefings — all developed to AMA/Vancouver referencing standards using primary sources including PubMed, WHO, FDA, EMA, and CIOMS.
Areas of Expertise
Medical & Scientific Writing — Comprehensive drug monographs, Medical Information–ready reference documents, and patient education materials grounded in current pharmacology and pivotal trial data.
Systematic & Evidence Synthesis — Literature reviews employing GRADE evidence grading and Bradford Hill causality criteria, with rigorous critical appraisal of the primary literature.
Pharmacovigilance — ICSR case narrative drafting, MedDRA v26.1 coding (LLT–SOC), Naranjo causality assessment, and ICH E2B(R3)-compliant safety documentation.
Regulatory Affairs — FDA 510(k) and EMA GVP appraisals, ICH-GCP-aligned documentation, and regulatory intelligence writing.
Pharma Strategy & Landscape Writing — Patent-expiry timelines, biosimilar-pipeline analysis, and multi-jurisdiction pricing and reimbursement briefings.
My clinical experience — over 200 patient consultations and 1,000+ documented case records — has given me a rigorous foundation in structured documentation, evidence-based reasoning, and diagnostic risk assessment, skills that translate directly into clinical trial, safety, and regulatory writing.
I work efficiently with MS Word, Excel, and SharePoint-based document management systems, and use generative AI tools within a human-in-the-loop framework to enhance — never replace — writing quality and accuracy.
A full portfolio, including sample monographs, safety narratives, and regulatory analyses, is available upon request.