Service Representative Data Entry
Resume:
ARATEE SAPKOTA
El Cerrito, CA
******.**@*****.***
SUMMARY
Bachelor/Master’s degree in Pharmacology combined with Drug Safety training and hands-on internship. Interested in pursuing a career in the Pharmaceutical industry with a focus on Drug Safety and Pharmacovigilance, but open to other roles including clinical research, pre-clinical research, and regulatory. Willing to relocate for the right opportunity.
TECHNICAL SKILLS
Oracle Argus Safety Database (Version 8.0)
MedDRA coding (Version 21.0)
Understanding of HIPAA, ICH GCP Guidelines and Drug development process.
Knowledge of 21 Code of Federal Regulation parts 11, 50, 54, 56, 312.
Capable of Serious Adverse Event (SAE) reporting and Individual Case Safety Reporting (ICSR).
Microsoft Office Suite, Word, Power Point, Excel.
WORK EXPERIENCE
Customer Service Representative Jan 2020- Present
United Airlines-SFO
Forefront in the operation welcoming customers and assisting them with their needs.
Drug Safety Associate Intern Jan 2019-Dec 2019
Sollers – Edison, NJ
Perform case processing activities for adverse events from receipt to case closure in accordance with ICH-GCP and USFDA regulatory guidelines.
Data entry of Individual Case Safety Reports (ICSRs) including general information, patient information, medical history, laboratory data, suspect drug, concomitant medications, and adverse event coding into Argus Safety Database and performing quality check of ICSRs.
Perform case processing activities for adverse events from receipt to case closure in
accordance with ICH-GCP and USFDA regulatory guidelines. Focused on initial case
assessment to determine validity and triaging cases to prioritize seriousness.
Assessment of Case Reports for Seriousness, Causality and Expectedness.
Perform quality review for adverse events (AEs), serious adverse events (SAEs), and serious unexpected serious adverse reactions (SUSARs)
Code adverse events and drugs using MedDRA and WHO Drug Dictionary
Project Lead Pre-Clinical 2014-2015
Himalayan Pharmacy Institute, Sikkim, India
Study of the phytochemical effect on cognitive function in Streptozotocin induced diabetic rats.
Industrial Trainee 2011
Sun Pharma- Sikkim, India
Taking the finished product of a manufacturing process and ensuring that it is packaged in
line with company and industry standards, making it ready for sale or distribution.
Education
Master’s of Pharmacy (Pharmacology) -2015
Himalayan Pharmacy Institute - Sikkim, India
Bachelor of Pharmacy - 2012
Himalayan Pharmacy Institute - Sikkim, India
Work Authorization
Permanent Resident – Authorized to work without sponsorship.
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