Amgen is a globally recognized biotechnology company dedicated to serving patients living with serious illnesses. Established in 1980, Amgen has pioneered biotech advancements across four key therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. With a focus on innovation and collaboration, Amgen continues to develop and deliver groundbreaking medicines that improve patients’ lives worldwide.
Responsibilities in the Job
The Case Management QA Vendor Associate will play a critical role in ensuring high-quality case management processes in pharmacovigilance. Key responsibilities include:
- Supporting interactions with business partners (license partners) and vendors for case intake and processing activities.
- Overseeing vendor case quality, ensuring compliance with global regulatory requirements.
- Submitting individual case safety reports to FDA, EMA, business partners, and vendors.
- Acting as the US/EU local safety office and point of contact for safety reporting.
- Providing audit and external inspection support.
- Assuring quality of Individual Case Safety Reports (ICSR) for clinical trial and post-market cases.
- Managing vendor performance through metric analysis and quality control.
- Providing vendors with training and necessary resources.
- Supporting audits and compliance with corrective action plans (CAPAs).
- Ensuring vendor adherence to approved processes and training requirements.
Qualifications
Amgen is seeking a qualified professional who meets the following criteria:
Basic Qualifications:
- Bachelor’s degree with 3 years of directly related experience, OR
- Associate’s degree with 5 years of directly related experience, OR
- High school diploma/GED with 7 years of directly related experience.
- Prior experience managing teams, projects, or resources.
Preferred Skills
Candidates with the following skills and experience will be preferred:
- In-depth understanding of global regulatory requirements for pharmacovigilance.
- Proficiency in safety case processing and regulatory reporting.
- Experience with global safety databases and pharmacovigilance software.
- Strong knowledge of case intake and processing procedures.
- Experience in supporting inspections or internal audits.
- Excellent communication skills and attention to detail.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, and Project).
