Rohan Soneja

About Rohan Soneja

I have three years of experience as a Safety Data Analyst with Covance (now LabCorp Drug Development) in the Pharmacovigilance process. I have worked directly on adverse event reporting and product complaints of drugs, biologics, and medical devices. Specifically, I am experienced with call intake, case triaging, case processing, and quality review of ICSRs (Individual Case Safety Reports), this allowed me to develop my technical abilities such as Database handling (Sceptre, ArisG, Argus, and MedDRA), Microsoft Office and Data Analysis. While working as a Quality Reviewer with the Functional Quality Assurance Team (FQA), I developed my ability to collaborate, work with a team, ask for assistance, and effectively communicate across the upper management. The aim was to achieve high quality and productivity of data of the ICSRs so that the data is appropriate when it is submitted to the Regulatory Authority of the specific region. Being an experienced associate and working in quality review opened doors for me to train the new members of my team on database handling, case triaging, and case processing and assisted me to be a part of Audits. Therefore, this further advanced my assertive communication skills boosted my managerial abilities, and gave me an understanding of Regulatory and Process Audits. I am fascinated by new ideas, and I continuously adapt to make the process innovative during this transition, I have always learned and kept improving my subject knowledge. My current education in Regulatory Affairs will familiarize me with compliance requirements (GCP, GMP, GLP), Code of Federal Regulations (CFR), IND submissions, NDA & ANDA processing, clinical development, 510(k), PMA, Letter to File, and product labeling coupled with my previous work experience in post-market drug safety will give me concrete regulatory insights. I would like to connect with Regulatory Professionals across the globe, you can reach out to me at s••••••••@gmail.com or s•••••••@northeastern.edu

Experience

1. Global Clinical Affairs Device Specialist

   Insulet Corporation

   Jan 2025 — Present · Acton, MA, US

Education

• Maharashtra Institute of Pharmacy

  B.pharm, Pharmacy

• Northeastern University

  Master's degree, Regulatory Affairs

• Kalmadi Shyamrao Junior College

  High School, H.S.C, Science

• The Bishop's School, Pune

  School