Ajay Yadav

• Unabhängige Beratung und Überwachung von Pharmakovigilanzprojekten in CROs. • Unterstützung bei der Stärkung von Pharmakovigilanzkapazitäten und der Gewinnung internationaler Projekte • Künstlicher Intelligenz in Pharmakovigilanzprozessen • Beratung im Bereich klinischer Studien mit End-to-End-Lösungen – von der Studieninitiierung und Aktivierung der Prüfzentren über Monitoring, Datenmanagement und regulatorische Compliance bis hin zum Studienabschluss und der finalen Berichterstattung.

-ICSR Processing and Evaluation: -Processing, evaluating of single case reports (serious, Non serious, SAE, SUSAR) in Argus Safety database (Spontaneous, CT (Clinical Trials), PMS, Literature cases). Case Ageing Report monitoring. Certified MedDRA coder. To check SDs, RSI, PRG, case narratives, expectedness of events as per RSI, Seriousness of events per EMA-IME and write causality statement. Prepare AOSE (Analyses of similar events) for specified ICSRs from Switzerland. Review Line listings new product.

Research Analyst: Nov 2015- Apr 2016. Assisting in cross functional team activates and management. PV lead: May 2016- Mar 2017 ICSR Processing and Evaluation: assessment of individual case safety reports (ICSRs) and provide accurate and consistent coding of medical history, drugs and adverse event terms using MedDRA is done and further assess seriousness, labelling and causality for events. Review monthly errors report and Medical Analysis. Learning and participating in signal detection activities in PV

In Hospital, to diagnose and Treatment of patient's ailments, prescribing medicines, under Haryana Civil Medical Services, Govt of Haryana, India.

to diagnose and treatment of patients, working in medicines and general surgery departments, rotational working in different departments in hospital like Psychiatry, ENT, Eye, orthopedics, Obstetrics and Gynecology.

BLACK BELT (Team Management, Administration)