IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Essential Functions: - 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
Requirements: - Bachelors Degree in Health Science area fields (Pharmacist, PharmD, Registered Nurse)
- Minimum 3 years of experience in international Pharmacovigilance area
- Working knowledge of global Pharmacovigilance regulations
- Strong knowledge of medical terminology
- Excellent oral and written skills
- 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
Join Us
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
