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Integrated Signal Management
4 weeks ago
Key Activities:
- Performs product complaints statistical excursion trending deep dives
- Understand customer / patient use of Amgen s packaged and/or distributed mechanical and/or electromechanical products
- Understand manufacturing processes for Amgen s packaged and/or distributed products.
- Maintain close interaction with multiple functions including Quality (e. g. complaints, device quality, product quality, external supplier quality, manufacturing quality, quality engineering) and contribute to product / device design improvements
- Collaborate with other safety functions to support integrated surveillance of Amgen products from both quality and safety s perspectives
- Prepares and interprets adverse events and product complaints data supporting integrated product surveillance activities
- Prepares product and process surveillance metrics for internal safety and quality governance forums
- Pulls complaints and/or adverse events data to support ad-hoc analysis and regulatory inquiries
- Perform data verification of complaints data pulled for inspection requests
- Applies analytical skills to evaluate complex situations using multiple sources of information
- Contribute to technology innovation initiatives related to post market surveillance, including AI/ML and automation opportunities
- Contribute to improvements in trending methodologies and process improvement opportunities
- Support audits and inspections as appropriate
Knowledge and Skills
Required Knowledge and Skills:
- Quality and/or manufacturing experience in biotech or pharmaceutical industry
- Complaints or complaints trending within a development, manufacturing, or post-market environment
- Knowledge of product complaints and adverse events intake and processing process
- Ability to pull and create product complaints and/or adverse events data per request
- Knowledge of medical devices or combination products, ideally Class II and Class III
- Data querying skills and experience with data visualizations tools such as Tableau, Power BI, or Python
Preferred Knowledge and Skills:
- Proven experience with mechanical and/or electromechanical medical devices
- Knowledge of combination products and medical devices, including device safety monitoring regulations and standards
- Ability to perform data analysis and derive insights
Education & Experience (Preferred)
- Degree in Engineering or Life Science
- 5-9 years of quality and/or manufacturing experience as an engineer in the biotech or pharmaceutical industry
- 2+years of experience in complaints or complaints trending within a development, manufacturing or post-market environment, working with medical devices or combination products, ideally Class II and Class III
- Experience with statistical trending methodology, preferably complaints
- Strong data analysis experience and a passion for finding correlations across different datasets
- Experience with data querying and business intelligence tools
- Strong presentation and teamwork skills