Daniela Mitreva Pehlivanova
About Daniela Mitreva Pehlivanova
Daniela Mitreva Pehlivanova is a Study Data Manager at Bayer HealthCare, where she has worked since 2016. She specializes in evaluating safety reports, overseeing vendor queries, and developing training for compliance with medical device regulations.
Work at Belcan
Daniela Mitreva Pehlivanova has been serving as a Study Data Manager at Belcan TechServices for Bayer HealthCare since 2016. In this role, she is responsible for the initiation of Corrective & Preventative Actions and the development of training related to impacted processes. Her work involves evaluating individual case safety reports for off-label use and medication errors, ensuring compliance with global medical device regulations. Additionally, she oversees vendors and makes medical decisions on queries escalated by them.
Education and Expertise
Daniela Mitreva Pehlivanova studied at Medicinski universitet - Sofia, where she achieved her MD in Internal Medicine and Gastroenterology/Hepatology from 1979 to 1985. This educational background provides her with a strong foundation in medical knowledge and expertise, which she applies in her current role. Her proficiency includes developing targeted questionnaires for scrutinized pharmaceutical products and providing guidance on MedDRA term selection for safety-related information.
Background
Prior to her current position, Daniela worked at the VA Medical Center in Kansas City, MO, as a Co-investigator and Research Associate in the Division of Gastroenterology & Hepatology from 2001 to 2004. This experience contributed to her extensive knowledge in medical research and safety evaluations, further enhancing her capabilities in her current role at Bayer HealthCare.
Achievements
In her role at Bayer HealthCare, Daniela chairs and prepares Product Teams meetings focused on safety signal detection. She addresses designated medical events, suspected unexpected serious adverse events, and events of special interest. Her responsibilities also include conducting in-line medical safety reviews of individual case safety reports, particularly for medical devices and drug-device combinations in areas such as birth control and hemostasis.