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Regulatory Reporting - Operations Specialist Manager (Pharmacovigilance) - Homebased
IQVIA Holdings Inc.
Zagreb, Croatia
Regulatory Reporting – Operations Specialist Manager
Be a part of a global team to help ensure the safety profile of a COVID-19 vaccine with opportunities to improve worldwide public health.
Provides comprehensive safety services across the lifecycle of pharmaceutical compounds and medical devices, from first in human clinical trials through post-approval, marketed product, and regulatory safety requirements.
Job overview:
Support Regulatory reporting global initiatives
Provides comprehensive safety services across the lifecycle of pharmaceutical compounds and medical devices, from first in human clinical trials through post-approval, marketed product, and regulatory safety requirements.
Collects, tracks, and reports adverse events or clinical outcomes; analyzes and reports aggregate safety data; performs safety surveillance; and performs benefit-risk evaluation and planning.
Provides data gathering, entry, and reporting services on behalf of contracted customers, including both clinical trial and marketed product safety activities.
Triages, tracks, and processes safety data
Assess safety data for report-ability to the client safety department or relevant regulatory bodies
Maintains communication (phone, fax, email) with investigative sites or marketed product reporters to obtain accurate data regarding safety events and contributes to lifecycle safety deliverables
Subject Matter expert – process improvement
Qualifications:
5 years +, pharmacovigilance experience
Life science or Healthcare degree
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At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
Job posted: 2021-03-05