Mandeep Gulati

Background

About Mandeep Gulati

Versatile, well-organized, and highly tenacious healthcare professional with more than 8 years of experience in Pharmacovigilance and clinical research industry. Experience includes end to end processing of Individual case safety reports (ICSRs), medical writing, literature searches and true solicited cases with diverse therapeutic areas. Possess good working knowledge of international drug safety regulations, including ICH & FDA guidelines, Volume 9A, Health Canada guidelines, CIOMS, European Union regulations and guidelines, Good Clinical and Pharmacovigilance practices. Expertise in management of Individual Case Safety Report (ICSR) that includes triage, initiation, Medical Review, Data Entry (ADRs/ADEs) and Quality Review of ICSRs. Responding to safety requests from regulatory agencies or affiliates and liaising with the internal and external experts to obtain specialized medical expertise. Provided training and mentored PV scientists in various activities of case processing. Proficient in MS Office (Word, Excel, Powerpoint), MedDRA coding, Micromedex, and possess expert knowledge of various drug safety database (ARGUS, AEGIS, AWARE, PRIMO, RAVE). Excellent communication skills along with good organizational, interpersonal and presentation skills and great leadership qualities.