RCI-KVUE1-429 Quality Complaints Specialist (Pharma/Medical Device)

Description:

• The Analyst III triages, evaluates and determines if investigation is necessary for product quality complaints and adverse events for the Self-Care product portfolio of Client Consumer products in accordance with Standard Operating Procedures using the Product Quality Management System.
• This may include but is not limited to review of complaint case to verify customer verbatim, lot number, subject coding, malfunction coding, trend analysis, assignment of complaint to investigation team.
• The Analyst III investigates product quality complaints, review of manufacturing and packaging investigations, complaint summary, complaint closure and escalation.
• Performs field sample management process for products returned from Consumer.
• Collaborates with Call Centers, Medical Safety, Marketing, Internal affiliates, External sites, and other business partners to ensure the integrity, consistency, compliance, and alignment of the end-to-end complaint vigilance process.
• Assists with developing training presentations for complaint vigilance process and systems and creation and updates of controlled documents.
• As necessary, this position will support the Triage, Investigation, and field sample function in other Geographical regions for Consumer products.
• The Analyst III must have the ability to assist with/participate in various projects within the department, communicate effectively with management.
• This role will analyze data and other trends.
• Will prepare and present Complaint Vigilance data to QA Management and cross functional business partners.
• This role reports to the Manager, Self-Care Complaint Vigilance.
• Participates directly or indirectly on regional and global complaint vigilance initiatives, and project teams to develop, consolidate, and/or improve complaint vigilance and related/interfacing processes.