Ambreen B
Drug Safety Specialist ll at Halozyme, Inc. | New York City Metropolitan Area
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Ambreen B. is a dedicated Drug Safety Specialist II at Halozyme, Inc., where she leverages her four years of experience in Pharmacovigilance (PVs) to ensure the safety and efficacy of pharmaceutical products throughout their lifecycle. With a robust understanding of global drug safety regulations, Ambreen excels in managing both clinical trial and post-marketing safety activities. Her expertise in coding with MedDRA and WHO Drug Dictionary within Argus and ArisG platforms allows her to effectively process and analyze individual case safety reports (ICSRs) from various sources, including collaborating partners and published literature.
In her current role, Ambreen is responsible for the uniform and timely intake of safety cases, ensuring compliance with ICH-GCP and USFDA regulatory guidelines. She plays a critical role in reviewing clinical trial and post-marketing safety information, contributing to the preparation of periodic safety update reports (PSURs) that are essential for regulatory submissions. Her analytical skills and attention to detail are vital in assessing safety data, identifying deviations, and implementing corrective actions to uphold the highest standards of quality control.
Ambreen's proficiency in triage and her strong organizational skills enable her to prioritize tasks effectively, ensuring that safety concerns are addressed promptly. Her critical thinking abilities allow her to navigate complex safety scenarios, making informed decisions that enhance patient safety and regulatory compliance. As a key member of Halozyme's drug safety team, Ambreen B. is committed to fostering a culture of safety and excellence in pharmacovigilance, ultimately contributing to the success of the company’s innovative therapies.
Drug Safety Specialist ll at Halozyme, Inc. in December 2022 to Present
Sr Pv specialist at ProPharma Group in March 2022 to September 2022
Drug Safety Associate at Johnson & Johnson in July 2021 to April 2022
Provider Customer Service Representative II Xtend Healthcare21 at Navient in January 2021 to May 2021
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Karnataka State Women University, Bijapur, Bachelor of Science - BS, October 2026
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Medical Terminology
Product Labeling
Call Monitoring
Attention to Detail
Triage
U.S. Food and Drug Administration (FDA)
Corrective and Preventive Action (CAPA)
Deviations
Medical Coding
CRO Management
Good Manufacturing Practice (GMP)
Regulatory Requirements
Case processing
Icsr
WHO dictionary
Adverse Event Reporting
Pharmaceutical Industry
Good Clinical Practice (GCP)
Quality Control
Windows
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Discover more about Halozyme, Inc.What is Ambreen B email address?
Email Ambreen B at [email protected]. This email is the most updated Ambreen B's email found in 2026.
How to contact Ambreen B?
To contact Ambreen B send an email to [email protected]. (updated on September 05, 2024)
What company does Ambreen B work for?
Ambreen B works for Halozyme, Inc.
What is Ambreen B's role at Halozyme, Inc.?
Ambreen B is Drug Safety Specialist ll
What is Ambreen B's Phone Number?
Ambreen B's phone (212) ***-*214
What industry does Ambreen B work in?
Ambreen B works in the Biotechnology industry.
Ambreen B Email Addresses
Ambreen B Phone Numbers
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