Brett Loop is a high-skilled professional, who works in Amgen main office of which is in 207. on the position of Director, Pharmacovigilance and Risk Sciences, Global Patient Safety from 2020. This person gained professional experience in more than 11 positions at various companies. Brett Loop went to the The Johns Hopkins Bloomberg School of Public Health and got education there from 2008 to 2010. Boston, Massachusetts is the area, where this professional was lastly known to be living. The professional's contacts can be easily accessed through SoftwareOfficial on demand.
Name variants:
Bret Loop,
Bretta Loop
Last updated Jul 04, 2024
Contact Information
Workplace
Director, Pharmacovigilance and Risk Sciences, Global Patient Safety
Newbury Park, CA
Industry
Biotechnology
Colleagues
Work History
Director, Pharmacovigilance and Risk Sciences, Global Patient Safety
1 Amgen Center Dr, Thousand Oaks, CA 91320
from Feb 2020
Senior Manager, Health Economics and Outcomes Research
50 Northern Ave, Boston, MA 02210
from Nov 2016
Associate Director, Aggregate Reports and Risk Management, Global Patient Safety
50 Northern Ave, Boston, MA 02210
Global risk management lead for Kalydeco (ivacaftor), tezacaftor/ivacaftor and VX-371
Medical writing and project management for global aggregate reports (PSUR, DSUR, PADER), Risk Manageme...
Feb 2015 — Nov 2016
Senior Manager, Aggregate Reports and Risk Management, Global Patient Safety
50 Northern Ave, Boston, MA 02210
Global risk management responsibilities for Kalydeco (ivacaftor)
Medical writing and project management for global aggregate reports (PSUR, DSUR, PADER), Risk Management Plans and Post Aut...
Apr 2013 — Feb 2015
Senior Manager, Pharmacovigilance Operations, Global Patient Safety
50 Northern Ave, Boston, MA 02210
Daily oversight and management of intake, processing and reporting for global clinical and marketed safety reports for Incivek and Kalydeco
Global case volume of ~30,000 reports/year
Main...
Mar 2012 — Apr 2013
Manager, Global Patient Safety
50 Northern Ave, Boston, MA 02210
Support production of aggregate reports including telaprevir PSUR/DSUR and ivacaftor PADER
Produce developmental risk management plans (dRMP) for rheumatoid arthritis (VX-509) and epilepsy...
Jan 2011 — Mar 2012
Senior Patient Safety Specialist, Patient Safety
Gaithersburg, MD
•Assist in planning, development and execution of pharmacovigilance program for 2009 H1N1 Influenza A vaccination program
•Train, manage and support offshore business process outsourcing uni...
May 2008 — Jan 2011
Senior Patient Safety Specialist, Global Patient Safety
1 Medimmune Way, Gaithersburg, MD 20877
Assist in planning, development and execution of pharmacovigilance program for 2009 H1N1 Influenza A vaccination program
Train, manage and support offshore business process outsourcing uni...
May 2008 — Jan 2011
Clinical Quality
Gaithersburg, MD
•Utilize TrackWise Quality Management Software in creation and execution of Deviation, CAPA and VSCR.
•Create, revise and review standard operating procedures via EDMS.
•Support and Coordina...
Aug 2006 — May 2008
Quality Control Techician Ii, Clinical Quality
1 Medimmune Way, Gaithersburg, MD 20877
Utilize TrackWise Quality Management Software in creation and execution of Deviation, CAPA and VSCR.
Create, revise and review standard operating procedures via EDMS.
Support and Coordina...
Aug 2006 — May 2008
Education
2008 — 2010
2000 — 2003
2000 — 2003
Occupations
Executive
Manager
Sales Specialist
Supplier
IT Professional
Data Analyst
Scientist
Biotechnology Professional
Operations Manager
Director of Operations
Data Entry Specialist
Chief Revenue Officer
Safety Specialists
Partner
Services Professional
Sales Representative
Data Scientist
Biologist
Biological Scientist
Chief Executive
Skills
Good pharmacovigilance practice
Risk Management
Safety signal detection
Pharmacovigilance
Empirica signal
PSUR
Argus Safety
Epidemiology
Risk Management Plans
ARISg
Eudravigilance
CAPA
Microbiology
Quality Management
Six Sigma
Trackwise
Validation
FDA
GMP
Vaccines
Regulatory Submissions
Regulatory Affairs
Healthcare
Drug Development
Psur
Good Pharmacovigilance Practice
Medical Writing
Safety Signal Detection
Fda
Gmp
Capa
Biotechnology
Gcp
Oncology
Arisg
Empirica Signal
Clinical Trials