PQV Trending & Monitoring Analyst 4
About The Position
The PQV Trending and Insight Analyst 4 performs and leads activities associated with trend analyses, signal detection, complaint data analysis, metrics, and insights within the Product Quality Vigilance organization. This role supports the development and implementation of quality, product-specific surveillance strategies through proactive, customer-focused detection and evaluation of potential signals from emerging trends in complaint data. The position serves as a key interface with product quality owners, quality integrators, manufacturing sites, clinical, product value-stream, medical safety, quality systems, and other business partners to ensure awareness, assessment, and appropriate escalation of complaint signals. The Analyst applies technical, statistical, product, and process knowledge to transform raw complaint and product data into meaningful insights that support risk-based decision-making, quality improvement, regulatory readiness, and complaint vigilance governance. The PQV Trending Analyst supports individual complaint investigation review, utilizing global visibility to support and coach local sites and will use this vantage point to lead improvement projects.
Requirements
- Bachelor’s degree in a technical, scientific, engineering, statistics, microbiology, data analytics, quality, or related discipline is required; equivalent experience may be considered where applicable.
- Minimum of 5+ years of related experience, including experience working in pharmaceutical, consumer, medical device, quality assurance, quality control, complaint management, post-market vigilance, risk management, compliance, or another highly regulated industry.
- Advanced knowledge and proficiency in Microsoft Excel for data analysis and signal detection, including macros, tables, lookups, and related analytical functions.
- Demonstrated ability to communicate effectively verbally and in writing, including technical writing, data storytelling, persuasive communication, and presentations to multiple organizational levels.
- Global mindset with demonstrated ability to lead change initiatives, manage projects, develop strong relationships, influence without authority, and work independently in a cross-functional environment.
Nice To Haves
- Master’s degree, MBA, or advanced degree in a technical, scientific, engineering, statistics, quality, business analytics, or related discipline is desirable.
- Green Belt, Six Sigma, CQE, formal investigation training, data analytics certification, or equivalent quality/process improvement certification is preferred.
- Experience with signal detection, complaint trending, product quality monitoring, or data-driven quality surveillance activities is preferred.
- Experience working with large datasets, complaint systems, quality systems, data processes, dashboards, or technical reporting is preferred.
- Working knowledge of complaint handling, quality system regulations, and regulated industry expectations, including applicable GMP, GDP, GVP, medical device, pharmaceutical, and combination product requirements, is preferred.
- English required; multilingual capability is an asset.
Responsibilities
- Lead, conduct, and support complaint trending, signal detection, and data analysis activities for product quality complaints across global products and manufacturing sites.
- Evaluate complaint information from a technical, product, process, and data perspective to ensure appropriate trend analysis, signal evaluation, investigation linkage, and documentation are completed prior to escalation, closure, or governance review.
- Act as a PQV point of contact for manufacturing sites and cross-functional business partners on trend insights, signal awareness, aging or coming-due signal assessments, prioritization, data quality, and complaint analysis needs.
- Provide guidance, coaching, and support to internal and external business partners on complaint trending expectations, data interpretation, report outputs, and related quality system requirements.
- Support regulatory inspections, audits, health authority requests, Complaint Vigilance Review Board discussions, business partner requests and senior management reviews by preparing clear data outputs, analyses, explanations, and recommendations.
- Execute transactional tasks to support the complaint management process (data collection/ review, complaint record review, etc)
- Lead global, cross functional improvement projects.
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- 10 days Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
