PC Triage and Intake Associate

In this vital role you will be part of the Global Patient Safety organization this team implements Intake and Triage of product complaints (PCs), adverse events (AEs) and other safety findings (OSFs).

Their focus includes assuring compliant processes and systems remain fully compliant through the pharmacovigilance and quality operating standards and procedures to current, emerging internal and external requirements.

In addition, the team translates information from the market to drive continuous improvement.

The PC Triage and Intake Associate is responsible for global triage of Product Complaints and ensure proper Adverse Events and/or Other Safety Findings were captured. Ensure to capture the patient outcome because of the reported event.

This position ensures compliance with global and local procedural documents and local implementation of Amgen Corporate, Patient Safety, and Quality objectives, policies, processes, and procedures.

• Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes.
• Triage of initial data entry (book-in) of new PC, AE and OSF cases is complete.
• Performs the initial book-in activities and appends additional information or documents to the case as they are received in the global intake system.
• Ensures compliance with global and local procedural documents and local implementation of Amgen Corporate, Patient Safety, and Quality objectives, policies, processes and procedures.
• Supports performance emphasized culture.
• Ensures quality of PC, AE and OSF records.
• Implements Standard Operating Procedure requirements for the triage process.

• Masters degree and 3 years of Drug Safety or Life Sciences experience OR
• Bachelors degree and 5 years of Drug Safety or Life Sciences experience

• Pharmacovigilance, or Quality experience in biotech, pharmaceutical or medical device industry
• Bachelors Degree in a health-care subject area or scientific field
• Previous experience with a corporate intake system or safety database
• Ability to successfully manage workload to strict timelines
• Familiarity with basic project management tools
• Demonstrated ability to consistently deliver on-time, and high-quality results
• Ability to operate in a matrixed or team environment
• Understanding of the applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices).