PQV Combination Product Analyst IV

Beerse, Antwerp, Belgium, Ringaskiddy, Cork, Ireland, Schaffhausen, Switzerland

Quality

Quality Assurance

Professional

The PQV Combination Product Analyst 4 will be responsible for handling high-volume E2E product quality complaint activities and adverse events, including performing Medical Device Reporting (MDR) assessments. Additionally, the Analyst IV Combination Products will provide instruction and feedback to the group as needed and ensure completeness and consistency of complaint and MDR documentation. The position manages and collaborates with business partners and stakeholders (Out Sourced Management Team, Clinical, PV, IT, Local Operating Companies, ESIQ, Call Centers, Brand Protection, External Manufacturing Sites, Internal/External Manufacturing Sites, QA, Business Quality, Medical Safety and R&D) to deliver effective change management, drive process improvements and identify opportunities to improve the accuracy, efficiency and timeliness of the complaint and MDR processes.

This may include risk assessing the impact of proposed changes to the complaint handling/MDR process within and across functional/regional areas and supporting the global change management effectively. The Analyst IV must have the ability to lead projects and communicate effectively with all levels of management as part of stakeholder engagement and change management roll out.

• Perform high-volume end-to-end complaint handling activities, including, but not limited to:
  Intake, triage and review of the event reported, determination of MDR reportability, recovery of field samples for evaluation, determination of Priority/Non-Priority, and QP notification to LOC. Additional activities include due diligence to be performed with the complainant/intake centers/LOC, trend analysis, defect coding, risk criticality assessment, ensuring accurate/holistic investigation, and review and closure.
• Evaluate complaints to determine if the QTL’s or ULC’s have been exceeded, assess the level of investigation required, and assign to the applicable site for investigation.
• Governance and oversight for daily thru put of complaints and MDR decisions to ensure prioritization and KPI are met.
• Perform MDR evaluations and document written justification to support reportable and non-reportable regulatory decisions.
• Monitor complaints for new malfunction events that may require inclusion in the malfunction description list (MDL).
• Serve as a PQV point person for post market and complaint handling regulatory/MDR questions and inquiries; provides guidance and direction to subordinate Analyst roles and other PQV functions.
• Evaluate information from a technical perspective to ensure appropriate analysis and investigations/ MDR’s are accurately assessed for risk prioritization and performed per procedures, standards, and regulations.
• Back-up Product Quality Vigilance Investigation Support (PQVIS) personnel to support increased volume of complaints.
• Strong collaboration with Global Medical Safety, manufacturing sites, and LOC/BQ for effective complaint handling/MDR assessments and adverse events with potential product quality issues.
• Use technical and product knowledge to provide accurate feedback for escalation/awareness of issues and for current product enhancements/future product development, if applicable.
• Ensure that uniform and timely management of complaint records and regulatory reporting occurs per procedures, standards, and regulations.
• Compile and analyze data, metrics, and trends associated with the complaint handling processes.
• Support internal and external audits and inspections; ability to communicate regulatory and process…