Kuldeep P.

I have over 5 years of professional experience, with over 4 years dedicated to serving as a Japanese Resource specializing in Product Implementation, Validation/Testing, and Customer Support in Japanese. My expertise extends to the Pharmacovigilance/Life Sciences domain, encompassing a deep understanding of the Defect/Bug Life Cycle, Operational Qualification (Test Case) designing and execution, and Management and Verification for Platform/Environment upgrades. I possess a strong foundation in regulatory compliance, including familiarity with GDP, CAPA, 21 CFR Part 11, Drug Life Cycle, RFC, FSD, and ICSR.E2B R2 & R3. My technical proficiencies include working with Oracle Argus/Argus-J, Cognos, Jira, SQL, Case Management, Quadrant, and Transform PV. Furthermore, I have hands-on experience in requirements gathering, implementation, and product support, along with delivering end-user trainings for pharmacovigilance and safety systems. My responsibilities have also involved managing electronic submissions and exchanging safety data such as ICSRs, SUSARs, and Japan Periodic Safety Reports. I excel in configuring and implementing expedited and aggregate reports, including Japanese regulatory reports to PMDA. Moreover, my proficiency in the Japanese language allows me to communicate fluently with Japanese customers and accurately translate requirement and functional specifications, as well as test documents, from Japanese to English.