Monica Manik

Monica Manik is a skilled professional in pharmacovigilance and regulatory affairs, currently serving as a Pharmacovigilance and Regulatory Specialist at the University of Colorado Anschutz Medical Campus since April 2023. Prior experience includes roles such as Pharmacovigilance & Regulatory Affairs Associate at XBiotech USA, Inc., where Monica authored Development Safety Update reports and configured the Argus Safety Database for various studies. Additional experience encompasses positions in clinical operations and regulatory affairs, where responsibilities included quality review of clinical electronic trial master files and drafting essential regulatory documents. Monica's educational background includes a Master's degree in Regulatory Affairs from Northeastern University and a Bachelor's degree in Pharmacy from C.U. Shah College of Pharmacy.