Priya Reddy

Background

About Priya Reddy

5+years of experience in reporting both clinical and post marketing adverse drug events in pharmaceutical industry. Worked in various therapeutic areas like oncology, vascular disease, central nervous system and gastroenterology. Experience in managing workflow steps for cases which include triage, case processing, medical review, quality control of case prior to submission. Remarkable knowledge to monitor and track Serious Adverse Events, serious and non-serious adverse drug reactions, and other medically related project information. Working effectively with focus and great attention using experience knowledge of US FDA, EMEA and ICH- GCP guidelines and regulations governing clinical trial safety environments. Contributed to the preparation and review of safety risk section(s) of Investigator brochures, PSUR, DSUR, PADER. Proficient in data entry and using drug safety databases like ARGUS and ARISg. Supported signal detection for all products and identified sources of information and data base searches to retrieve data for evaluation of signals. Experience in support inspection preparedness activities policies and practices as per Company SOPs Acted as a safety liaison by contacting to other departments and licensing partners. Excellent written and oral skills, work is done in organizational manner. Good leadership qualities and helped colleagues to perform difficult task in timely manner.