Periodic Report Safety QC Reviewer – Amgen

If you’re an experienced professional in pharmacovigilance or medical safety writing, here’s your opportunity to join Amgen, a global biopharmaceutical leader. The Periodic Report Safety QC Reviewer role in Hyderabad, India, offers a chance to contribute to global patient safety by ensuring accuracy and regulatory compliance of periodic safety reports like PBRER, DSUR, and PSUR.

This position is ideal for life sciences or pharmacy graduates with strong analytical and quality review skills who want to work in a dynamic, compliance-driven safety environment.

🧾 Key Responsibilities

As a Periodic Report Safety QC Reviewer, your responsibilities will include:

• Conducting comprehensive QC reviews of PBRERs/PSURs, DSURs, PADERs/PAERs, and other safety reports.
• Ensuring data accuracy, narrative alignment, and formatting consistency per regulatory and Amgen standards.
• Verifying safety data, narratives, and appendices for consistency with source databases.
• Collaborating with report specialists to resolve discrepancies quickly.
• Staying updated with global pharmacovigilance regulations and best practices.
• Supporting QC process improvements, checklist optimization, and SOP refinement.
• Tracking QC metrics to enhance report quality and delivery efficiency.

🎓 Required Qualifications

• Education: Bachelor’s or Master’s in Life Sciences or Pharmacy.
• Experience: Total 5–9 years; at least 2–3 years in Quality Control of safety reports.
• Strong understanding of pharmacovigilance, aggregate reporting, and global regulatory submissions.
• Excellent attention to detail, communication, and document review skills.

💼 Why Join Amgen?

• Work with a global leader in biotechnology and life sciences.
• Be part of a dynamic pharmacovigilance team impacting patient safety worldwide.
• Competitive compensation and career advancement opportunities.
• Exposure to global regulatory frameworks (EMA, FDA, MHRA, PMDA, etc.).

📍 Job Details

• Position: Periodic Report Safety QC Reviewer
• Location: Hyderabad, India
• Work Type: On-site
• Company: Amgen
• Job ID: R-219720
• Posted On: November 13, 2025
• Valid Through: December 13, 2025
• Salary Range: ₹10 – ₹18 LPA (depending on experience)

🚀 How to Apply

Application Link