Associate Director, QA - Pharmacovigilance Functional Strategy (R1053814) in Dublin, Ireland at IQVIA™

Date Posted: 6/21/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Date Posted:
    6/21/2019
  • Job ID:
    R1053814

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Role Purpose

To be a trusted partner to the function head and team, providing prospective, strategic QA input into operational improvement initiatives, and QA analytics and insights to drive continuous improvement.  The role is also key in ensuring robust and effective issue management and assisting operations to maintain inspection readiness at all times, in rapidly evolving clinical development and regulatory environments.

  • Process Assessments
    • Conduct annual Process Robustness Assessment and ongoing risk analysis of Pharmacovigilance (PV) systems and processes to recommend process audits for the Global Annual Audit Plan
    • Review process audit plans and audit reports, and support the audit team in agreeing the CAPAs
    • Work with PV counterparts to maintain Key Core Processes (KCPs) and associated EDA classifications
    • Monitor progress with PV Process Owners’ strategies and action plans to improve existing KCPs
    • Support the investigation of current/recurring key issues or findings relating to PV by reviewing the existing processes, CAPAs to identify gaps and make recommendations to the Lead QA and operations.
  • CAPA Management
    • Support and oversee/facilitate, where required, the processing of Quality Issues in accordance with CS_OP_002, (Manage Critical Process-Related QIs and Critical Multi-Customer Related QIs as Lead QA. Provide consultation on the review of CAPAs, Critical Notification Forms and Serious Breaches) for PV.
    • Maintain oversight of the status of approved preventive actions to address improvement opportunities with PV processes.
    • Work with the PV Functional Head and their representatives to ensure efficient and timely processing of audit reports/findings and Quality Issues in their domain.
  • Process Improvement Initiatives and New Service offerings
    • Monitor, catalogue, proactively contribute to, track the actions agreed from, and work with operations to establish the effectiveness of improvement initiatives undertaken by PV
    • Monitor, catalogue, proactively contribute to the development of new service offerings relating to PV, and work with operations to establish the effectiveness of those offerings  
    • Provide consultancy and input into incremental process improvements, such as advising on SOP content
  • Customers and Regulators
    • Maintain an up-to-date knowledge of emerging regulations, and emerging/changing interpretations of regulations, and changing expectations of regulatory inspectors, assess the risks and feedback recommendation to PV, and be available to support operational management in interpreting regulations.
    • Maintain strong links with Customer Account Leads to monitor emerging/changing expectations of customers with respect to PV’s systems and processes, assess the risks and feedback recommendation to the function
    • Host or support Regulatory inspections as the SME for PV
    • Host or support customer audits as the SME for PV
  • Insights and Reporting
    • Review audit findings and Quality Issue/ Nonconformance events as they relate to PV on an ongoing basis
    • Conduct trend analyses
    • Identify QA insights to feedback to PV management
    • Produce periodic QA reports on PV performance
    • Facilitate periodic management quality reviews with PV and capture and track agreed actions
    • Collaboration with Quality Managers (QMs) to remain aligned on emerging Operational risk trends
  • Support QA colleagues
    • Support QA colleagues in the oversight of the practices of other Business Areas conducting work allied to PV
    • Provide updates and overviews of the insights and initiatives associated with PV
    • Share the identified KCP level action plans with others in QA to prevent repetitive Preventative action plans 
  • Contribution to Functional QA Strategy
    • Contribute ideas for improvements in the services of the Functional Strategy Team, and to the development of new, more impactful, efficient or effective ways of working.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Circa 5 years’ experience working in Pharmacovigilance Quality Assurance.
  • Experience working with a CRO is desirable, but not a pre-requisite
  • Experience in hosting customer audits and regulatory inspections is an advantage, but not a pre-requisite
  • Strong knowledge of pharmaceutical research and development processes and regulatory environments.
  • Detailed working knowledge of quality assurance processes and procedures.
  • Strong interpersonal skills and the ability to positively influence and guide others whilst building and maintaining effective working relationships.
  • Excellent problem solving, risk analysis and negotiation skills.
  • Possess experience in conducting audits, writing audit reports and analysing audits.
  • Demonstrated ability to lead and manage multiple responsibilities.
  • Ability to identify functional constraints and identify solutions.
  • Ability to coordinate timelines with internal customers and external vendors.
  • Demonstrated experience of maintaining up to date knowledge of regulatory requirements, including changes in requirements and expectations.

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™



Job ID: R1053814