Bryan Kawata Email & Phone Number

Alameda, California, United States

Alameda, CA

• Management of individual case submissions by generating and transmitting XML/E2B files, CIOMS, and MedWatch reports to the FDA, EMA, and various regulatory authorities for post-marketing and clinical trial reports.
• Assists in overseeing the workflow of cases within Drug Safety Operations to ensure that expedited cases are submitted before the internal deadline.
• Responsible for the management of the Drug Safety Operations Late Case Tracker. Responsibilities include: tracking, organizing/analyzing information, and compiling a monthly report that is distributed to the Chief.

South San Francisco, CA

• Responsible for providing operational support in various areas of Safety such as intake, submissions, and case processing.
• Triage and management of the drug safety email inbox to ensure all safety related cases and requests are assigned to the appropriate associates for processing.
• Perform initial evaluation and case assessment of incoming safety related information.
• Responsible for the continued training and integration of our outsourcing group on the intake of all safety related cases and email inbox management.
• Accountable for co-writing intake drug safety SOPs with our Drug Safety Workflow Manager.
• Generates and manages follow-up queries to health care providers.

Foster City, CA

• Accountable for the accurate and timely book-in and acknowledgement of adverse event information in compliance with applicable Gilead SOPs and in accordance with pharmacovigilance related standards.
• Process adverse event reports supplied by solicited programs, clinical trials, regulatory authorities, clinical/spontaneous literature, and other spontaneous sources.
• Extensive use of the Local Affiliate Module in Argus Safety Database to import safety information and provide quality control for reports provided by various regulatory authorities and other sources.
• A liaison for developing and implementing Gilead’s newest module for Intake Drug Safety. In a select group, created a database to improve workflow, compliance, and organization.
• Collaborates closely with other members of the Drug Safety team including case managers, safety physicians, and the triage team to comply to FDA regulations.
• Proficient in appropriate methods to handle and uphold pharmacoviligant agreements between Gilead and their partners.

San Francisco

-Performed various pulmonary function and blood tests (spirometry, diffusing capacity, nitrogen washout, altitude simulation, arterial blood sampling, co-oximetry blood sampling) on clinic, hospital, and clinical study patients-Testing involved instructing and properly coaching very ill patients to perform demanding and effort-dependent breathing tests..

-Assisted staff with patient scheduling -Fabricated lenses for patient prescription eyewear -Participated in office meetings -Called insurance companies to verify vision service plans-Participated in meetings with pharmaceutical sales representatives -Adhered to all office procedures and policies

Bachelor'S Degree, Nutrition Science, Minor In Biology, Alumni

Activities and Societies: Tau Kappa Epsilon

Associate'S Degree, General Education

Activities and Societies: Member of the 2010 and 2012 Santa Ana College Baseball team