Job title: Case Quality Management
Company: IQVIA
Job description: Major duties and responsibilities:
Case Quality & Process Management is a global centralized role that oversees ICSR quality by: • analyzing in-process quality checks, reporting of results, tracking quality findings, metrics against, defined KPIs; • analyzing quality deviations, identifying root causes, adjudicating ICSR corrections with corresponding issuance of CAPA, as appropriate, to evaluate CAPA effectiveness; • driving continuous process improvement for Case Management by partnering with all entities, Country Safety Leads, License Partners, and vendors; • overseeing CAPA management for Case Management; • managing vendor quality activities, identifies opportunities for improvement; managing Case Management compliance; • overseeing the in-process workflow of all ICSRs and implementing strategies to prevent late ICSR reports; • serving as a SME during internal / partner audits and Health Authority inspections in this role.
Skills and Education:
Working knowledge of global pharmacovigilance regulations; strong knowledge of medical terminology; excellent communication skills; computer literacy, use of MS Office (e.g. Word, Excel, ect.); must have excellent oral and written skills in English • Working knowledge of Pharmacovigilance databases, ICSR processing conventions and coding; strong analytical skills, ability to analyze raw data and summarize findings/gaps and implement corrective actions; ability to multi-task and work under pressure in order to meet timelines. • Minimum of three years of experience in international pharmacovigilance area; certified degree in a Health Science area (Pharmacist, PharmD, Registered Nurse) or a minimum of 5 years of experience in ICSR management.
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
Expected salary:
Location: Bangalore, Karnataka
Job date: Sun, 24 Jul 2022 02:52:27 GMT
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