Mayur Ikhankar

About Mayur Ikhankar

Drug Safety Associate with 2+ years of experience specializing in pharmacovigilance and drug safety operations demonstrated expertise in adverse event case processing and regulations compliance. Proven track record in quality review of ICSRs and maintaining pharmacovigilance database. Skilled in cross-functional collaboration and committed to ensuring patient safety through precise safety data management. Thank you!

Experience

1. Drug Safety Associate

   Tata Consultancy Services

   Jul 2023 — Present · Nagpur, IN

   Processing of individual Case Safety Review (ICSR) from Phase IV, Clinical trials, non-interventional program/study origin, Post marketing Surveillance and Spontaneous reports. • Responsible for generating and forwarding appropriate acknowledgement, queries and requests for clarification and follow- up information. • Trained in ICSR case intake team responsibilities such as triaging & prioritizing the ICSRs based on source of the reports, seriousness, causality & labelling under a defined regulatory framework. • Accurate MedDRA coding of adverse events, medical history. • Writing perfect, chronological and concise medically relevant safety narrative for different types of ICSRs. • Performing Case Intake by adding mandatory parameters in Safety Database. • Responsible for identifying duplicate ICSRs in Argus and handling as per relevant ICSRs. • Managed expedited and periodic safety report submission to regulatory authorities, maintaining 100% compliance with submission timelines. • Executed listedness assessment against product labels and collaborated with medical staff for query resolution and data completeness. • Supported database reconciliation and maintained documentation for adverse event reporting requirements across multiple countries.

Education

• Priyadarshini J. L. College of Pharmacy

  Bachelor of Pharmacy - BPharm

  2016 — 2020

• Priyadarshini J. L. College Of Pharmacy

  Master of Pharmacy

  2020 — 2022