Aayushi Sahu Email & Phone Number

I am a skilled, passionate and efficient professional with well-versed knowledge of Pharmacovigilance and Clinical Research. I maintain a positive outlook and a flexible approach towards work and interactions with people, supported by my strong organizational skills. This combination enables me to effectively prioritize workloads and consistently meet deadlines. My objective is to seek a career in an organization where I can utilize the skills and knowledge I possess, put my learning into practice and make contributions. I am fully equipped with the relevant skills of pharmacovigilance, including, but not limited to,• Hands-on experience of processing 100+ ICSRs with sound knowledge of standard timelines.• Hands-on experience in MedDRA coding, ensuring accurate classification and documentation of adverse events in compliance with regulatory requirements."• Experience in Literature screening.• Exposure to aggregate reporting in pharmacovigilance, including timelines and standards, as per different countries.• Comprehensive knowledge of safety databases, encompassing Duplicacy check, Case Book-In, and Complete case entry.• Deep understanding of WHO-DD.• Understanding of Signal Management.• Comprehensive knowledge of global pharmacovigilance guidelines.• In-depth understanding of processing special case scenarios.• Knowledge of CAPA Management.My knowledge of clinical research lies in • Drug development process• Clinical trial phases• IND, NDA Applications• Informed Consent• Case Report Forms• Protocols• SOPs