Case Quality Management

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.

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 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.