Scott Yee Email & Phone Number

United States

Working with programs such as Medwatch, CIOMS, and ARISg to complete daily assignments assigned to me.Collecting, documenting, and processing of adverse event (AE) reports/complaints from clinical trials and post-marketing sources.Prepared case narratives in accordance to CIOMS V, particularizing information that is medically relevant to the adverse events reported.

United States

Received and entered adverse drug events, as well as follow-up from vendors, clinical trials, and spontaneous complaints from consumers and healthcare providers into ARGUS database. Processing of adverse events (includes receipt, assessment of Listedness, seriousness criteria / labeling, case prioritization and request follow-ups) based on regulatory requirements. Performed the initial review of SAEs including assessment of drug-relatedness and expectedness, coding of the events using MedDRA dictionary and the writing narratives. Written clinical narrative summaries independently for SAE/AE reports from clinical studies and spontaneous post-marketing reports and formulated follow-up information requests. Ensured timely reporting of SAEs/AEs to Regulatory Authorities, and cross reporting to pharmaceutical partner(s). Ensured regulatory compliance for individual expedited cases and case report submissions to Health Authorities or other receivers as appropriate. Accepted E2B cases received through Argus Electronic Submission Module (ESM) as necessary and processed prior to routing to PSSR. Performed quality review and checking cases for discrepancies for any errors related to labeling and narrative writing.

United States

Collected, documented, and processed adverse event (AE) reports from clinical trials and post-marketing sources adhering to Standard Operating Procedures. •Prepared clinical narrative summaries for 'Adverse Event'. •Performed active follow-up via telephone contact with consumers and health care professionals. •Participated in periodic review and updating of SOPs and working practices to ensure they remain compliant. •Assess Safety reports for report ability to authorities and create comprehensive narrative for all adverse events that have occurred across sites for review by medical team. •Ensured timely coverage to Regulatory Authorities and pharmacist. •Participated in preparing safety reports and maintained clinical databases. •Performed medical coding using MedDRA and WHO-Drug dictionaries and composes case narratives. •Determined follow-up requirements and recommend follow-up. •Coding relevant medical terminology composed descriptive narrative and generated advanced condition queries. •Quality control checks of adverse event for accuracy and completeness. •Prepared safety reports and utilized regulatory and medical knowledge to assess claims. •Ensured compliance by informing senior management of any process gaps with respect to FDA regulations and guidelines for marketed and investigational products, and recommended changes where applicable.

Education record

Bachelor Of Arts, Biological Sciences And Psychology