Arushi Kant

About Arushi Kant

A regulatory affairs enthusiast and a pharmacovigilance expert with over 9 years of experience in drug safety performing end to end processing of ICSRs, aggregate report writing and Signal detection and Management for four of the world’s top 10 multi-national biopharmaceuticals companies.An individual with perseverance, patience, ability to work hard and an unceasing curiosity to learn, I have conducted myself at my workplace with nothing less than my best possible and have been constantly rewarded with bigger responsibilities.I am currently working as a Global safety Manager in Safety signal Management at Amgen. In my 9 years in Drug safety, I have been a business owner of internal signal tracking tool, process owner of the signal management and safety governance process, and collaborated cross functionally to enable improved PV capabilities in the signal and risk management space. I have authored aggregate reports including but not limited to Periodic Benefit Risk Evaluation Reports (PBRERs)/Periodic Safety Update Reports (PSURs), PADERs, Ad-Hoc reports, and writing report sections for assigned products including planning, writing and coordinating production of the report. I am also adept in performing quality review of reports.I have also performed End of Line (EOL) quality review of statistically significant sample of Individual Case Safety Reports (ICSRs). I was working closely with the Team Manager (as an Associate Team Manager) in handling the EOL team.I began my pharmacovigilance career with processing ICSRs from all sources (spontaneous, clinical studies, solicited programmes, Regulatory authority reports and literature) for drugs and medical devices, including: Triage, Data entry of ICSRs in the safety database (includes working on Argus, Aware and Sceptre), including determining the expectedness of adverse events against various labeling documents (such as SPC, IB, USPI, CCDS etc.), writing case summaries, assessing causalities and writing CIOMS comments if required.I also have Expertise in MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”I have performed review and validity assessment of literature abstracts and full articles, identifying events for coding, query identification and tracking and experienced in handling cases involving medical devices.I am also well versed with EMA and FDA regulations, specifically EMA’s Good Pharmacovigilance Practices and CIOMS guidelines pertaining to PV.

Experience

1. Global Safety Senior Manager- Signal Management

   Amgen

   Nov 2023 — Present · CA, US

Education

• Panjab University

  B.Sc. (honours), Biotechnology

• Panjab University

  M.Sc, Biotechnology

• Northeastern University

  Master of Science in Regulatory Affairs of Drugs, Biologics and Medical devices

  2018 — 2019

Skills

• Cell Biology
• Stem Cells
• Plant Tissue Culture
• Immunology
• Intellectual Property
• Molecular Biology
• Patents
• Enzymology
• Recombinant Dna Technology
• Biochemistry
• Animal Cell Culture
• Genetic Engineering
• Microbiology
• Environmental Biotechnology
• Genetics