Pharmacovigilance Quality Assurance Manager
The IQVIA QA team is a dynamic, talented, and experienced global team that owns the global quality management system for the largest human data science company in the world. The QA function is responsible for driving compliance in a highly regulated industry through audits, functional support, issue & CAPA management, regulatory consultancy, management of data analytics and customer relationship interactions. These services ensure our clinical research and post marketing activities are of the highest quality. We proactively support our business partners and help to drive innovation.
This position is a QA Manager in the Pharmacovigilance and Commercial QA team who will serve as a PV QA subject matter expert within IQVIA. The QA Manager is responsible for supporting quality programs for the systematic monitoring and evaluation of the various aspects of projects, services and/or functions in the post-marketing regulatory space, in order to drive compliance to Good Pharmacovigilance Practice (GVP) along with other applicable GxPs and relevant regulation and to ensure that projects, processes and deliverables are in compliance with regulatory requirements and industry best practices.
Internally focused activities
- Support in the risk assessment of processes/systems, and the development of the annual process audit plan.
- Contribute to the design and delivery of process audits.
- Ensure the Quality Assurance database is maintained and up to date to reflect the status of audits being scheduled, auditor assignment and audit reporting and/or follow-up status.
- Oversee and participate in the documentation, reporting, and closure of compliance issues.
- Supports the analysis of trends in quality issue reporting and timeliness to ensure adherence to quality issue management requirements across project teams.
- Supports the analysis of quality and operational data to proactively identify continuous improvement opportunities for the PV and Commercial space
- Prepares for and actively participates in periodic meetings with internal stakeholders to discuss quality issues and trends
- Assist with interfacing with senior operational management to discuss quality and compliance issues impacting the PV and Commercial space.
- Assist in providing guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies.
- Assist in update and maintenance of Quality Assurance Standard Operating Procedures (SOPs) related to PV and Commercial QA.
Client focused activities
- Collaborates with key stakeholders to ensure projects are audit and inspection ready.
- Collaborates with Customer QA teams and with internal project teams to host and/or support customer audits of IQVIA and Regulatory Inspections of the Customer.
- Reviews and approves CAPA plans resulting from audit or inspection findings and confirms implementation and effectiveness of the actions taken.
- Acts as the internal PV QA point of contact for IQVIA project teams.
- Supports the IQVIA project team with the management and resolution of significant issues relating to quality.
- Assists in facilitation of communication between Customer QA teams and internal project teams to promote, support and facilitate the quality of IQVIA’s deliverables to the Customers.
Required Education and Experience:
- Bachelor’s degree in a scientific or healthcare-related field
- Three (3) to 5 years prior relevant experience.
- Minimum 2 years of post-Marketing experience in pharma or CRO setting.
- Advanced English level
Required Knowledge, skills and abilities:
- Thorough understanding of GVP and applicable GxPs and regulatory requirements applicable in the post-marketing space and demonstrated experience interpreting and applying relevant regulations, laws and guidance.
- Practical experience applying proactive quality approaches for post-marketing services.
- Knowledge in the conduct of audits and inspections, and the development of corrective action plans
- Strong negotiation and influencing skills; demonstrated ability to work constructively and effectively at all levels across functions as well as with external customers
Travel: Up to 20%
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 https://jobs.iqvia.com