Global Quality Specialist / Manager at IQVIA

IPV.Work closely with IPV Affairs members across regions to ensure a globally consistent approach for IPV.Own and coordinate Quality investigations/Quality Issues (QIs) and related records (CAPAs/Corrections) on behalf of IPV personnel - Originating from Self-Identified Quality Issues, Audit Findings, and/or Inspection Observations.Coach relevant stakeholders through the applicable QI processes.Support in writing investigations and conducting root cause analysis to ensure high quality, consistency, and accuracy of content.Collaborate with Medical Safety Teams/LSOs, Case Management team members, and other relevant stakeholders to identify appropriate solutions to mitigate non-conformances and prevent recurring issues.Maintain oversight of IPV-owned records and ensure timely completion and closure of records.Act as a Subject Matter Expert within IPV for all matters related to QI and CAPAs, providing advice or support on questions/concerns related to it.Review audit and inspection reports

and support trending of observations to lead to overall global improvements.Support IPV in maintaining audit and inspection readiness for all IPV related activities.Support IPV Audit and Inspection RFI coordination - provide ETS Local, Regional/Global QI data as needed.Education & Experience RequirementsMedical, pharmaceutical, or life science degree with proven expertise and experience in the pharmaceutical industry and experience in Pharmacovigilance.Minimum of 1 year's experience in a position within Pharmacovigilance plus 6-8 years of related experience.Excellent stakeholder management, negotiation skills, and coaching people in influencing internal and external partners.Task-oriented with proven experience in the delivery of high-quality work as part of a multi-disciplinary team.In-depth understanding of vigilance systems and processes; knowledge of or experience with International Pharmacovigilance and compliance regulations and guidelines is an advantage for this
role.Demonstrable insight into the development of regulatory requirements with knowledge of Global aspects of drug/cosmetics/devices safety, including international reporting requirements and relevant country-specific variations.Excellent computer-based application skills.Fluent communication skills in English; any additional language is a plus.Location & TravelGlobal Office-based role from any Pharma office in the correspondent region. Remote work is possible.Up to 25% travel might be required.About IQVIAIQVIA 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 How to ApplyClick the "APPLY NOW" button to submit your application. #J-18808-Ljbffr