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High Salary PC Triage and Intake Associate
1 month ago
In this vital role, you will be part of the Global Patient Safety organization, focusing on the intake and triage of product complaints (PCs), adverse events (AEs), and other safety findings (OSFs). You will ensure compliance with global and local procedural documents, as well as with Amgen's corporate, Patient Safety, and Quality objectives. This position is critical for translating information from the market to drive continuous improvement and ensure that all patient safety data is handled accurately and in a timely manner.
Roles & Responsibilities
- Triage & Intake: You will be responsible for the global triage of Product Complaints, ensuring proper Adverse Events and/or Other Safety Findings are captured. You'll perform initial data entry (book-in) and append additional information as it's received in the global intake system.
- Compliance & Quality: Ensure compliance with global and local procedural documents and implement Standard Operating Procedure requirements for the triage process. You will be responsible for the quality of all PC, AE, and OSF records.
- Collaboration & Timelines: You will work within the Quality Management System framework and have the ability to successfully manage your workload to strict timelines. This role supports a performance-emphasized culture and requires a demonstrated ability to deliver high-quality results consistently.
- System & Process Management: Use a corporate intake system or safety database to perform your tasks. You'll also support the implementation of Amgen's policies and processes, ensuring that pharmacovigilance and quality operating standards are met.
Qualifications
- A Master's degree or a Bachelor's degree with a background in Drug Safety or Life Sciences.
- Previous experience in a corporate intake system or safety database is preferred.
- Experience in pharmacovigilance or quality in the biotech, pharmaceutical, or medical device industry is a plus.
- An understanding of applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices) is preferred.
Soft Skills
- Attention to Detail: Ensures quality of PC, AE, and OSF records and accurate data entry.
- Time Management: The ability to successfully manage your workload to meet strict timelines.
- Collaboration: The ability to operate in a matrixed or team environment.
- Problem-Solving: A demonstrated ability to consistently deliver high-quality results.
