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Company Name : IQVIA
Location : Bengaluru, Karnataka
Position : Submission Reviewer
Job Description : Major duties and responsibilities:
Performs regulatory reporting in all major regions in accordance with policies, SOPs and HA regulations, • has oversight of the reporting rules configuration for compounds, marketed drugs, consumer healthcare products, 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; • 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; • is the SME during internal / partner audits and inspections
Skills and Education:
computer literacy (e.g. Microsoft Office); working knowledge of pharmacovigilance databases; strong attention to detail; ability to work independently; excellent verbal and written skills in English; understands intake, distribution, and submission rules for ICSRs to regulatory agencies, affiliate countries, license partners/ collaboration partners. • Able to multi-task and work under pressure to distribute and submit ICSR reports on time to prevent late distributions/submissions; • Technical Degree preferred; 1 to 2 years of data entry experience preferred; experience working in a local/global pharmaceutical company
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com
This post is listed Under Bengaluru jobs
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