
PC Triage and Intake Expert
3 days ago
As a key member of our team, you will play a critical role in ensuring the quality and compliance of pharmacovigilance processes. You will work within a framework that adheres to all applicable training and controlled documentation governing these processes.
Key Responsibilities:- Triage initial data entry (book-in) of new PC, AE, and OSF cases is complete.
- Perform initial book-in activities and append additional information or documents to the case as they are received in the global intake system.
- Evaluate compliance with global and local procedural documents and local implementation of corporate objectives, policies, processes, and procedures.
We value diversity and unique contributions. As a team member, you will support a performance-emphasized culture and ensure the quality of PC, AE, and OSF records.
Qualifications:- Master's degree and 3 years of experience in Drug Safety or Life Sciences, or Bachelor's degree and 5 years of experience.
- Preferred qualifications include Pharmacovigilance or Quality experience in biotech, pharmaceutical, or medical device industries, Bachelor's Degree in a health-care subject area or scientific field, previous experience with a corporate intake system or safety database, ability to manage workload to strict timelines, familiarity with basic project management tools, demonstrated ability to deliver high-quality results on-time, and ability to operate in a matrixed or team environment.
- Understanding of global regulatory requirements, including Good Manufacturing Practices and Good Pharmacovigilance Practices.
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Hyderabad, Telangana, India Amgen Inc Full timeJob DescriptionKey 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...
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