
Scientific writer with experience managing end-to-end US and EU medical information activities, including escalation resolution, content lifecycle management, and cross-functional stakeholder engagement. Responsibilities include authoring and maintaining clinical FAQs and Standard Response Documents; conducting scheduled and ad hoc content reviews triggered by publications, conference data, and regulatory label changes; and maintaining Global Work Plans across a product portfolio. Skilled in literature searching (PubMed, Embase, Ovid) to support evidence-based responses; performing scientific accuracy and fact-checking review of MI content and peer-authored slide decks; and managing documentation in Veeva Vault, Docuvera, and IRMS. Experienced in presenting portfolio metrics to leadership, liaising between affiliates, content owners, and reviewers, and creating disease-state and training slide decks, infographics, and data visualizations with structured Document Content Overviews (DCOs) for clear navigation and communication. Also leads evaluation and adoption of AI tools (Claude, MediAuthor, Copilot) within medical information workflows, designing pilot programs and prompting strategies to improve content development efficiency while preserving compliance standards.
M Shaju A, Panicker N, Chandni V, Lakshmi Prasanna VM, Nair G, Subeesh V. Drugs-associated with red man syndrome: An integrative approach using disproportionality analysis and Pharmip. J Clin Pharm Ther. 2022 Oct;47(10):1650-1658. doi: 10.1111/jcpt.13716. Epub 2022 Jun 22. PMID: 35730973.
Description: The purpose of this study is to identify the drugs which have the potential to induce Red Man Syndrome by exploiting the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Also, off-label targets (OLTs) of the drugs causing the event are determined by adapting the novel PHARMIP method.