Mohd. Aasim Saifi

Associate Scientific Writer @Indegene

Bengaluru, IN

Carried out SLR, TLR and evidence synthesis through Literature Screening, Data Extraction and analysis from Scientific Database includingPubmed/Medline, Embase, Web of Science and Cochrane to provide high-quality evidence-based support for Clinical and Regulatory Submission. Authored Clinical Overview document as per CTD Module 2.5 for Regulatory Submission, including label justification and local labelingspecifications for Core Data Sheet (CDS), Summary of Product Characteristics (SmPC), United States Prescribing Information (USPI), RiskManagement Plans (RMPs), Product Information (PI) update. Health Authority (HA) Response Document preparation to response the FDA, EMA, MedSafe, HAS, MHLW and MHRA etc Queries. Summa of Change (SOC) document preparation with systematic comparison of current and previous version, Clear justification of each change(scientific, technical, or editorial), Seamless integration into variation, amendment, or renewal submissions. Contributed to projects involving Real-World Data (RWD) and Real-World Evidence (RWE) by summarizing research articles, Literature Review andAnalysis, assisting in trend analysis, and supporting HEOR initiatives through extraction of outcomes data relevant to health economics and patientsafety profiles. Produced Scientific Slide Decks to support HEOR deliverables into clear, focused and actionable presentation to communicate RWE,Patients - reported Outcomes (PROs) data and Burden-of-illness Studies for External and Internal Stakeholders.