Mahitha M. Email & Phone Number

Remote

Wilmington, Delaware, United States

• Participate in the triage process for incoming documents to ensure timely and effective medical and scientific evaluation of adverse event information.
• Perform clinical data review and clinical evaluation on follow-up analysis of regulatory reporting and management of adverse event (AE) reports for investigational and marketed products within safety database like.
• Perform Electronic Reporting (E2B) of all necessary reports to the regulatory authorities, ensuring successful submission
• Prepare and revise individual case safety reports (ICSRs), Suspected Unexpected Serious Adverse Reaction (SUSARs), IND Safety Reports including narrative, coding, labelling, independent company causality assessment.
• Prepare and Review of clinical study protocols and amendments, study SAE forms and instructions, review of study data management plans, clinical data review plans, data listing reviews, and all other study documents or.

North Chicago, Illinois

• Executed surveillance activities for European Union and US authorized compounds in clinical development and for post-marketed products.
• Performed signal detection through review of data from multiple sources, including clinical trial and PV database.
• Contributed towards signal assessment and ad hoc safety requests by analyzing data from global safety databases.
• Experienced in case processing of the ICSRs which are obtained from post marketing surveillance and medical literature

Springfield, Illinois Metropolitan Area

• Assisted Program with development and submission of annual CDC grant application and documentation processing.
• Reviewed lab reporting systems and recorded follow up on cluster investigation in data base.
• Conducted comprehensive outbreak investigation using web-based application Redcap (Research Electronic Data Capture) for Food borne illness.
• Reported suspected or confirmed cases of infectious diseases electronically through a web-based system Illinois’ National Electronic Disease Surveillance System (I-NEDSS).
• Performed patient interviews and long-term case follow ups as a part of disease surveillance.
• Accessed census data within AVR (Analyzing, Visualizing and Reporting) for calculation population-based rates of the diseases.

Master Of Public Health - Mph, Epidemiology, A

Executive Mba, A

Doctor Of Pharmacy - Pharmd

Education record