Prateek Singhal

Background

About Prateek Singhal

I am a dedicated Senior Associate at Soterius Life Sciences India Pvt. Ltd. with a strong background in Pharmacovigilance and Drug Safety. Since joining Soterius in October 2022, I have been responsible for meticulously assessing and reviewing literature abstracts and full-text articles in compliance with rigorous regulatory standards. Effective communication with stakeholders is a fundamental aspect of my role as I execute operational responsibilities.My previous experience as a Specialist at PharmaLex India Pvt. Ltd. equipped me with comprehensive skills in case processing and data entry of Individual Case Safety Reports (ICSRs), adhering to global safety databases. I'm well-versed in critical tools like Sapphire and AB-CUBE-SYSTEM, ensuring the highest quality and regulatory compliance. Collaborative project organization, quality review, and proactive engagement with Medical Advisors were key components of my responsibilities during this tenure.As a Pharmacovigilance Associate at CAB Clinical Services India Pvt. Ltd. from October 2018 to March 2021, I developed expertise in case processing, MedDRA coding, and WHO Drug Dictionary. I managed the download of ICSRs from the EMA database, performed quality checks, and contributed to the configuration of the Argus safety database. Additionally, I actively engaged in writing investigations, root cause analysis, and ensuring high-quality, consistent content in collaboration with Medical Safety Teams and other stakeholders.My commitment to excellence, strong work ethic, and dedication to maintaining high-quality standards have been constants throughout my career. I'm passionate about ensuring compliance with regulations and guidelines, and I'm always eager to take on additional responsibilities to support my team and organization.I am excited to continue my journey in the pharmaceutical and life sciences industry, leveraging my experience and expertise to contribute to the success of my future endeavors."