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

Direct Reports: 4 FTEs

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).