Edward Nagy

Background

About Edward Nagy

Medical doctor with 18+ years increasing responsibility in pharmaceutical medicine with experience in patient safety/pharmacovigilance and clinical drug development across multiple therapeutic areas. Therapeutic areas- immunology-inflammation: JAK inhibitors: tofacitinib, ritlecitinib; & monoclonals, biologics (Crohn`s disease, ulcerative colitis, systemic lupus erythematous, rheumatoid arthritis, Sjogren’s syndrome, JIA, COVID, vitiligo, alopecia areata)- immuno-oncology/ oncology: small molecules, monoclonals, biologics (solid tumours including breast, lung and ovarian carcinoma, mesothelioma)- haematology: multiple myeloma, leukaemia, lymphoma - respiratory: asthma, COPD, allergic rhinitis - rare disease: DMD Current role- Senior Director-MD, Inflammation & Immunology, JAK inhibitors portfolio. Patient Safety at Pfizer, Safety Surveillance & Risk Management, Worldwide Medical Safety Responsibilities (current and past)- safety medical governance of assigned products including representing Safety and leading teams at project milestone meetings and internal governance boards: risk management committee, safety advisory panels, labelling committee - accountable for providing strategic oversight and direction for all regulatory safety responses or strategic deliverables including but not exclusive to safety sections of NDA submissions, RMPs, PSURs, PBRERs, DSURs, DILs - leading safety sections at regulatory meetings: FDA advisory committee, CHMP/PRAC oral explanation, PRAC Article 20 procedure - safety signal management and evaluation - provide safety oversight, strategy and guidance to therapeutic areas and other groups within clinical development, medical affairs, regulatory and epidemiology -people management: including line- and matrix management of large global multidisciplinary teams