Roles & Responsibilities
• Act as the US/EU local safety office representative and FDA/EMA point of contact
• Prepare and submit Individual Case Safety Reports (ICSRs) to FDA, EMA, and business partners
• Perform case review, quality checks, and escalation of case-level safety issues
• Ensure timely expedited safety reporting in compliance with global regulatory timelines
• Manage intake, triage, follow-up, and data entry queries related to ICSRs
• Support vendor oversight for case intake, processing, reconciliation, and quality metrics
• Conduct reportable event reconciliation for Amgen-sponsored clinical trials
• Perform business partner safety reconciliations as per safety agreements
• Provide LAO E2B support, including nullification and redistribution of cases
• Review non-matching data across clinical and safety databases
• Support audit readiness, health authority inspections, and internal audits
• Undertake delegated activities from the QPPV in line with the PV System Master File
• Assist in pharmacovigilance training and convention-related safety activities
• Initiate unblinding requests and support literature case review processes
Qualification
• Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, Clinical Research, or related field
Experience
• Bachelor’s degree with 2+ years of pharmacovigilance experience, or
• Associate degree with 6+ years of directly related experience, or
• High school diploma/GED with 8+ years of pharmacovigilance experience
Skills
• Strong knowledge of global pharmacovigilance regulations (US FDA, EMA, ICH)
• Hands-on experience in ICSR case processing and regulatory reporting
• Familiarity with clinical development and safety reporting workflows
• High attention to detail and strong case quality management skills
• Proficiency in safety databases and Microsoft Office (Word, Excel, PowerPoint, Outlook)
About the Company
Amgen is a leading global biotechnology company committed to discovering, developing, and delivering innovative medicines for patients with serious illnesses. With a strong focus on quality, compliance, and patient safety, Amgen offers a collaborative work environment and global exposure across pharmacovigilance and medical services functions.
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