Major duties and responsibilities:
Submission Reviewer is a centralized role that:
• Has oversight of the reporting rules configuration for compounds, marketed drugs,
devices, and vaccines to ensure proper distribution / submission to health authorities,
affiliate countries, license partners / collaboration partners.
• Has regulatory reporting expertise in all major regions.
• Performs regulatory reporting in all major regions in accordance with policies, SOPs
and HA regulations. Has oversight of ICSR submission related activities in all regions,
ensuring safety database is operational, prompt escalation of system outage affecting
ICSR distribution / submission process.
• Distribution of “Dear investigator letter” to investigators.
• Monitor “Distribution mailbox” and take appropriate action as per the received emails.
• Is the SME during internal / partner audits and inspections.
• Provide or receive training on Customer-specific processes, systems, or products.
• Other tasks as required.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
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What We Do
IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 70,000 employees, IQVIA conducts operations in more than 100 countries. To learn more, visit www.iqvia.com.
