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Amgen
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PC Triage and Intake Associate

PC Triage and Intake Associate

Amgen

3 - 8 years

3 - 5 Lacs

Hyderabad

Posted:3 days ago| Platform:

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Skills Required

Pharma Project management QMS Oncology Life sciences Pharmacovigilance Continuous improvement Drug safety Data entry

Work Mode

Work from Office

Job Type

Full Time

Job Description

Let s do this. Let s change the world. 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.

Job Summary

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.

Key Activities

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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Education & Experience (Basic)

Master s degree and 3 years of Drug Safety or Life Sciences experience OR
Bachelor s degree and 5 years of Drug Safety or Life Sciences experience

Education & Experience (Preferred)

Pharmacovigilance, or Quality experience in biotech, pharmaceutical or medical device industry
Bachelor s 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)

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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PC Triage and Intake Associate