Ralph Anthony Roa Email & Phone Number

Morristown, New Jersey, United States

• Serve as lead author and project manager to lead the preparation of DSURs and PBRER in accordance with ICH guidelines as required by health authorities
• Coordinate and organize safety data review information on a monthly basis for presentation to cross-functional team
• Perform quantitative safety data analyses using Excel to support new drug application, regulatory submissions, and signal evaluation activities

Peapack - Gladstone, New Jersey, United States

• Assisted Global Operations Drug Safety Unit E2B reports team by inputting reported adverse event data into Argus database within timeline guidelines with respect to FDA/global RA regulations
• Processed E2B cases from various license partners to verify validity, accuracy, consistency and compliance with Pfizer process requirements and license partner PVAs
• Data entry activities included identification and coding of adverse events, suspect product(s), concomitant medications, medical histories and laboratory data per company and license partner standards
• Other case processing activities included post-acceptance of expedited/non-expedited cases, split cases, duplicate search, follow-up, case merging, queries, notification of product complaints and reviewing and.

Madison, New Jersey, United States

• Reviewed over 3000 documents to identify and distinguish specific adverse event source documents fromarchived records as a part of a response to an inspection
• Utilized Argus for case lookups to ensure validity and identity of adverse event source documents from clinicaltrials and spontaneous reporting
• Utilized Box cloud software for online collaboration and DocuSign for documentation of workflow integrity
• Organized and led training sessions for colleagues and created workflow guidance during the initial phase of theproject

Madison, New Jersey, United States

• Performed overdue adverse event follow-ups on a monthly basis in collaboration with Romanian PV follow-upteam
• Corresponded with consumers and healthcare professionals via email, fax, and letter to seek further informationregarding reported adverse events
• Documented follow-up activities in accordance with Allergan/Abbvie standard operating procedures using Argus
• Collaborated with case processors to ensure accuracy and completeness of follow-up attempts

Livingston, New Jersey, United States

New York, United States