Job Description
Senior Pharmacovigilance AuditorPurpose
The Senior Pharmacovigilance Auditor is primarily responsible for planning, scheduling, conducting, reporting and closing internal audits as part of IQVIA Quality Assurance s Annual Audit Programme.
The audit programme focusses on IQVIA s post-marketing pharmacovigilance activities including those performed by Real World and Commercial offerings.
The Senior Pharmacovigilance Auditor will also be expected to work with the PV QA Director to contribute to IQVIA s strategic and tactical audit plans and, as the team grows, will be expected to support and mentor less experienced auditors.
Key responsibilities
Plan, schedule, conduct and report on internal audits of IQVIA s post-marketing pharmacovigilance activities
Review, approve and follow-up on corrective and preventive action (CAPA) plans to closure
As required, mentor and support less experienced PV auditors
As required, support the PV QA Director in the development of the risk-based annual, tactical and strategic audit plans.
Additional responsibilities
Plan, schedule, conduct and report on internal audits of IQVIA s Phase IV Real World studies
Provide Quality Assurance support, guidance and management of Quality Issues (significant deviations)
Provide Quality Assurance support to IQVIA project teams involved in Client-initiated audits or Regulatory inspections, which may include hosting of these audits or inspections and review of corrective action plans.
Provide Quality Assurance consultancy to IQVIA project teams and their Clients.
Assist in the provision of Quality Assurance data for Clients Pharmacovigilance System Master Files (PSMF).
Assist in the development and reporting of quality metrics for IQVIA s Quality Management System
ExperienceEssential
Five years post-marketing pharmacovigilance (GVP) experience in a Pharma or CRO environment
Three to Five years experience in conducting audits (on site and remote), writing audit reports and analysing audits.
Proven knowledge of quality assurance principles and processes
Strong interpersonal skills and the ability to positively influence and guide others
Excellent problem solving, risk analysis and negotiation skills.
Effective organization, communication, and team orientation and leadership skills.
Demonstrated ability to manage multiple responsibilities.
Desirable
Experience of GCP requirements and GCP auditing
Knowledge and understanding of Medical Devices
Auditing qualification (e.g. ISO 9001 Lead Auditor)
Qualifications
Bachelor s degree in a scientific or healthcare related field or equivalent
Travel
Travel up to 20% may be required
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 ()
The Senior Pharmacovigilance Auditor is primarily responsible for planning, scheduling, conducting, reporting and closing internal audits as part of IQVIA Quality Assurance s Annual Audit Programme.
The audit programme focusses on IQVIA s post-marketing pharmacovigilance activities including those performed by Real World and Commercial offerings.
The Senior Pharmacovigilance Auditor will also be expected to work with the PV QA Director to contribute to IQVIA s strategic and tactical audit plans and, as the team grows, will be expected to support and mentor less experienced auditors.
Key responsibilities
Plan, schedule, conduct and report on internal audits of IQVIA s post-marketing pharmacovigilance activities
Review, approve and follow-up on corrective and preventive action (CAPA) plans to closure
As required, mentor and support less experienced PV auditors
As required, support the PV QA Director in the development of the risk-based annual, tactical and strategic audit plans.
Additional responsibilities
Plan, schedule, conduct and report on internal audits of IQVIA s Phase IV Real World studies
Provide Quality Assurance support, guidance and management of Quality Issues (significant deviations)
Provide Quality Assurance support to IQVIA project teams involved in Client-initiated audits or Regulatory inspections, which may include hosting of these audits or inspections and review of corrective action plans.
Provide Quality Assurance consultancy to IQVIA project teams and their Clients.
Assist in the provision of Quality Assurance data for Clients Pharmacovigilance System Master Files (PSMF).
Assist in the development and reporting of quality metrics for IQVIA s Quality Management System
ExperienceEssential
Five years post-marketing pharmacovigilance (GVP) experience in a Pharma or CRO environment
Three to Five years experience in conducting audits (on site and remote), writing audit reports and analysing audits.
Proven knowledge of quality assurance principles and processes
Strong interpersonal skills and the ability to positively influence and guide others
Excellent problem solving, risk analysis and negotiation skills.
Effective organization, communication, and team orientation and leadership skills.
Demonstrated ability to manage multiple responsibilities.
Desirable
Experience of GCP requirements and GCP auditing
Knowledge and understanding of Medical Devices
Auditing qualification (e.g. ISO 9001 Lead Auditor)
Qualifications
Bachelor s degree in a scientific or healthcare related field or equivalent
Travel
Travel up to 20% may be required
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 ()
About IQVIA