Riya Goel

Background

About Riya Goel

Highly skilled professional persuing a Master’s degree in Pharmacovigilance and clinical research, honed with medical safety and advancing medical knowledge, clinical trial methodology, adverse event reporting standards, and pharmacovigilance concept. Receptive, very meticulous, analytical and dedicated to upholding the highest standard of patient safety. My skills in Pharmacovigilance and Clinical Research are- • A Registered pharmacist from Himachal Pradesh Technical University, Hamirpur. • Proficient in performing the review and evaluation of ICSR information for validity, seriousness, expectedness and causality assessment. • Practical experience in processing 200+ ICSR and in Screening 200+ Literature cases • Hands-on experience in MedDRA Coding, narrative writing • knowledge about safety databases including Duplicacy check, case book-In, complete case entry • Exposure to global pharmacovigilance activities and standards including ICH, GVP, 21 CFR, and CIOMS for developmental and/or marketed product • Exposure to clinical trial documents such as CRF, Protocol, SOP’s, Informed Consent • Thorough knowledge of Clinical Data Management • knowledge of the Drug Development Process starting from scratch to post-marketing of a drug including the Process from Pre-clinical to Phase l-lV. • Well-Acquainted with the process of various kinds of Applications & it's approval Processes including IND, NDA, ANDA with timelines and regulatory bodies (FDA, EMA, CDSCO) • Exposure to audits and inspection Ready to apply academic knowledge to real-world scenarios and thrive in a dynamic pharmaceutical environment.