ISHITA PATEL
SKILLS
DRUG SAFETY DATABASE: ARGUS, MedDRA v.14.1
COMPUTER SKILLS: Application: MS Office, Operating Systems: Windows 98, Windows XP
TECHNICAL: OC RDC 4.5, INFORM 4.6
PROFESSIONAL EXPERIENCE
ClifoMatrix- Flemington, NJ
Jun 2011- Present
Drug Safety Associate
BioBridges LLC-Boston, MA
Aug 2010- May 2011
Drug Safety Associate
Ensure effective reconciliation with clinical and safety databases (ARGUS)
Suggested and implemented quality improvement measures in case processing
Assessed and generated non-serious solicited and spontaneous cases
Obtained follow-up SAE information from clinical sites and CROs and responded to queries.
Processed cases using MedDRA and WHO-DRUG coding dictionaries
Ensured report, file, and database accuracy and completed all work within acceptable quality standards and determined timelines
Submitted expeditable safety reports to Regulatory Authorities, IRB/ECs, and investigational sites in accordance with relevant legislation and the project-specific contractual agreement, including electronic submission to the EudraVigilance database (EV Web application or Gateway)
Generates data listings from the safety database and assumes responsibility for accuracy of the data
Gathered information from a variety of global sources, including clinical trials, spontaneous, in compliance with company SOPs, U.S. and international regulations within strict timelines
Collaborated with physicians to manage case handling assessments
Regularly participated in quality improvement sessions to ensure efficiency and timeliness
Managed and maintain up to date case processing standards, ensuring accuracy
EDUCATION
Master’s of Medical Biology (Medical Chemistry)
Long Island University, Brookville NY-USA
Bachelor of Science in Pharmacy
A.R.College of Pharmacy, V.V. Nagar, Gujarat INDIA
