Integrated Signal Management (ISM) Engineer

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 :

Preferred Knowledge and Skills :

Education & Experience (Preferred)

Skills Required

Biotech, Pharmaceutical, Tableau, Power Bi