Positions
2022-Present
Vice President, Global Head of Medical Safety
Marketed Products, Global Patient Safety Evaluation
Takeda Pharmaceutical Co Ltd
The marketed products include indications in Oncology, Neurology, Rare diseases, Hematology, and Gastroenterology
Direct/Indirect Reports: 15 physicians supported by 20+ safety scientists
2022-Present
Associate Editor
Frontiers in Drug Safety and Regulations: Advanced Methods in Pharmacovigilance and Pharmacoepidemiology
2019-2022
Therapeutic Area Strategy Lead
Neurology and Ophthalmology
Sanofi Genzyme, Global Pharmacovigilance
Matrix Supervision: 8 FTEs
2017- 2019
Head of Signal Detection and Benefit Risk Assessment
Merck KGaA, Global Drug Safety Innovation
Matrix Supervision: 3 FTE
2013-2017
Executive Director, Pharmacoepidemiology.
Global Epidemiology Therapeutic Area Head for oncology, diabetes, cardiovascular, and benefit-risk assessment franchises, Merck Research Laboratories, Center for Observational and Real-world Evidence
Direct Reports: 8 FTEs, and Matrix Supervision: 3 FTEs
2011-2013
Deputy Division Director, Division of Pharmacoepidemiology (Population-based drug safety, Medical Officer Series).
HHS, FDA, CDER, Office of Surveillance and Epidemiology (OSE), Office of Pharmacovigilance and Epidemiology (OPE), Division of Epidemiology-I
Direct Reports: 20 FTEs
2009-2011
Associate Director of Pharmacoepidemiology (Population-based drug safety, Medical Officer Series).
HHS, FDA, CDER, Office of Surveillance and Epidemiology (OSE), Office of Pharmacovigilance and Epidemiology (OPE), Division of Epidemiology-I
Matrix Supervision: 5 FTEs
2006-2009
Team Leader, Analytic Pharmacoepidemiology /Drug Safety Data Management and Analysis Team (Medical Officer Series).
HHS, FDA, CDER, Office of Surveillance and Epidemiology, Division of Surveillance Research and Communication Support/ Division of Epidemiology
Matrix Supervision: 8 FTEs
2004-2006
Senior Medical Pharmacoepidemiologist (Population-based Drug Safety, Level III Reviewer, Medical Officer Series)
HHS, FDA, CDER, Office of Surveillance and Epidemiology (formerly known as the Office of Drug Safety), Division of Surveillance Research and Communication Support
2002-2004
Senior Medical Reviewer (Drug Safety, Level III Reviewer, Medical Officer Series) [1]
HHS, FDA, CDER, DNDP, now divided into Divisions of Neurological and Psychiatric Products
2000-2002
Medical Reviewer (Drug Safety, Level II Reviewer, Medical Officer Series) [2]
Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Drug Evaluation I (ODE I), Division of Neuropharmacological Drug Products (DNDP)
1996-2000
Director of Clinical Research and Medical Affairs
Nutramax Laboratories, Inc., MD
1994-1996
Graduate Research/Teaching Assistant
Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine
1988-1992
Primary Care Physician (General Practitioner)
Egyptian Ministry of Health hospitals and private practice
1991-1992
Associate Lecturer
Third year medical students, Minya University School of Medicine, Egypt
1988-1991
Instructor
Third year medical students, Minya University School of Medicine, Egypt
1986-1987
Medical House Officer (internship)
Cairo University School of Medicine and Ministry of Health hospitals, Cairo, Egypt.
[1] Level III Senior Reviewer: “An experienced, productive, superior reviewer who makes significant contributions to applications and technical problems within his/her Division, discipline, and throughout CDER. A Senior Reviewer demonstrates a thorough command of the review process and of regulatory science. The senior reviewer adapts well to team initiatives and deadlines, requires minimal supervision, participates in CDER initiatives, and demonstrates considerable interpersonal and communication skills.” Source: CDER Reviewer Career Path Procedures for Promotion to Level III (http://cdernet/crcp/mapp3.htm).
[2] Level II Reviewer: “A reviewer who has acquired general knowledge of the review process and completed the first phase of an Individual Development Plan to meet the core competency level for his/her discipline. A reviewer understands the basic tools of regulatory drug review and is capable of producing good reviews with some supervisory guidance. He/she functions as a team player and cooperates with others involved in the drug review process.” Source: CDER Reviewer Career Path Procedures for Promotion to Level III (http://cdernet/crcp/mapp3.htm).