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)
