PQSCA Data Scientist
Provide business program analysis and leadership, including system support, trending and metrics development, to ensure activities conducted for Alcon Product Quality Surveillance and Customer Affairs are in compliance with all regulations, guidelines, directives and standards established by the relevant regulatory agencies and Novartis. Support activities to maximize standardization and compliance while supporting changes to design, documentation and refinement of process work flows for efficiencies and concurrently managing/providing solutions to the business.
Monitor Alcon product performance in the field and key PQSCA processes ensuring end-to-end customer focus from intake to closure and customer response.
oDevelop and generate accurate and effective reports associated with complaint handling, customer response and Medical Product Information. oGenerate trending of technical quality complaints and preparation of signal detection reports for timely identification of quality issues. oInteract with other QA functions to provide timely feedback of product quality issues with potential for design related improvements.
oManage trending of customer responses/interactions to drive consistent and timely feedback efforts.
oGenerate accurate PQSCA data outputs.
- Collaborate with PQSCA management to develop a robust program to track internal processes and support continuous improvement by supporting the identification of process/data gaps, redundancies, and inaccuracies and preparing process improvement solutions to address.
oSupport the investigation of quality events (i.e., deviations) detected; provide support to the medical safety team and relevant functions on proper identification and escalation of quality related issues; ensure issues are appropriately escalated as per Novartis Quality Manual.
oProvide guidance to PQSCA personnel, as required, to identify, avert and/or resolve technical problems.
oCoordinate, define and monitor the PQSCA System Metrics and Trending Processes.
oProvide tools for PQSCA Management to oversee and maintain business process implementation.
oProvide direction and guidance regarding the impacts of data standards and data quality.
- Generate data for Quality Management Reviews to assess the continued suitability, adequacy, and effectiveness of the quality system throughout the product life cycle.
- Review and monitor data across functional areas to ensure consistency and application of data standards and data quality.
- Provide complaint handling, Quality Customer and Technical Affairs, Customer Oriented Device Programs, and MPI business support globally, including regional and affiliate levels.
oiTrack and IRMS (Information Request Management System) system Super-User, Subject Matter Expert (SME), and Process Owner.
oProvide systems support to all functions (MTO QA, Patient Safety, PQSCA, etc.) during internal and external audits for Complaints and Medical Information, as needed, globally.
Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to email@example.com and let us know the nature of your request and your contact information
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements •Bachelor's degree
- Fluent in written and spoken English.
- Minimum of 5 years work experience in a regulated medical device/Pharmaceutical industry
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