Preetha Prabhu

Background

About Preetha Prabhu

A proactive, determined and performance driven professional with over 10 years of experience working in the pharmaceutical industry spanning Regulatory Affairs and Pharmacovigilance. Working knowledge of Canadian Food and Drugs Act, regulations, guidelines and policies, ICH guidelines, Good Manufacturing Practices, principles of regulatory compliance and inspections. Hands-on experience supporting regulatory dossier submissions in eCTD format including NDS, SNDS, NCs and other post-approval level changes/amendments. Critically reviewing and assessing adequacy of Pharmacovigilance documents like PSUR/PBRER, Canadian ASR and RMPs to support regulatory submission. Thorough and extensive working knowledge of end-to-end patient safety data processing of SAEs/AEs and SUSARs with excellent clinical judgement. Extensive familiarity preparing and submitting Individual Case Safety Reports (ICSRs) using ARISg in timely manner without compromising accuracy and integrity. Provide subject matter expertise on MedDRA coding, screening of scientific literature for ADRs, causality assessment and regulatory requirements pertaining to report submission to Health Canada, EMA and other relevant health authorities.