Sunainpreet Kaur Nagi Email & Phone Number

Oakville, Ontario, Canada

Newmarket

India

-Triaged received ICSRs for reporting as per the guidelines for reporting and performed ICSRs submissions to EudraVigilance (EV), Health Canada and US FDA -Kept track on updates of latest regulatory policies of federal, state, and local regulatory agencies -Expertise in various databases and tools like ARGUS (version 7 and 8), AWARE, EUDRAVIGILANCE, ANNEX TOOL I, SCEPTRE, EUDRALINK, FAERS and FDA Web Trader Portal -Requested product complaint investigations on appropriate cases as… Show more -Triaged received ICSRs for reporting as per the guidelines for reporting and performed ICSRs submissions to EudraVigilance (EV), Health Canada and US FDA -Kept track on updates of latest regulatory policies of federal, state, and local regulatory agencies -Expertise in various databases and tools like ARGUS (version 7 and 8), AWARE, EUDRAVIGILANCE, ANNEX TOOL I, SCEPTRE, EUDRALINK, FAERS and FDA Web Trader Portal -Requested product complaint investigations on appropriate cases as per SOP -Assisted managers and team leads in supervising junior employees and lead team discussions -Supported team in preparing for inspections and audits -Organized and prioritized workload according to the regulatory obligations to ensure compliance -Performed and maintained MAH related updates on EudraVigilance -Performed submission of RMPs via Annex I tool and Eudralink -Supported in collecting, preparing and collaborating for aggregate reports including PBRERs, RMPs and PADERs -Performed regular quality check (quality control) of the data Show less

India

-Ensured that serious PMS ADRs are evaluated accurately and within the required timeframes to meet regulatory requirements -Worked independently as well as in cross-functional setting -Assessed seriousness, causality, and labeling of serious ADRs -Quality checked ICSRs to ensure accurate and consistent data entry from source documents -Delegated work as appropriate to junior employees -Helped mentor juniors and gave induction training to new entrants -Supported in… Show more -Ensured that serious PMS ADRs are evaluated accurately and within the required timeframes to meet regulatory requirements -Worked independently as well as in cross-functional setting -Assessed seriousness, causality, and labeling of serious ADRs -Quality checked ICSRs to ensure accurate and consistent data entry from source documents -Delegated work as appropriate to junior employees -Helped mentor juniors and gave induction training to new entrants -Supported in evaluation of signal detection (preparing the signal review spreadsheet for signal analysis) -Involved in analysis of the data during MedDRA up-gradation -Performed quality checks (quality control) for various safety documents -Distributed ICSRs to partners as per Safety Data Exchange Agreement -Made the team aware of any new latest update on any agreement -Organized and participated in project-specific training sessions -Communicated with clients for queries, prepared responses based on requests and host meetings with clients Show less

India

Crown College Certificate Program In Drug Safety And Pharmacovigilance Management And Ich-Gvp, Pharmacovigilance/Drug Safety

Bachelor'S Degree, Dentistry