Job Summary
Join Amgen’s safety team as a Periodic Report Safety QC Reviewer based in Hyderabad, India. This critical on-site role involves the quality control of global periodic aggregate safety reports such as PBRERs, PSURs, DSURs, and more. The ideal candidate will ensure compliance with regulatory standards, maintain document accuracy, and support continuous improvement of safety reporting.
Key Responsibilities
Perform detailed QC reviews of periodic safety reports including PBRERs, DSURs, PADER/PAERs, and country-specific submissions.
Ensure consistency and accuracy of data, narratives, and formatting across all reports.
Verify alignment between safety data and source systems/databases.
Collaborate with Periodic Report Specialists to resolve discrepancies.
Maintain knowledge of global PV regulations and reporting standards.
Assist in updating QC checklists, templates, and SOPs.
Track QC performance metrics and support process enhancements.
Required Skills & Qualifications
5–9 years of overall experience in pharmacovigilance or medical writing.
Minimum 2–3 years of experience in QC of safety documents.
Bachelor’s or Master’s degree in Life Sciences or Pharmacy.
Knowledge of global pharmacovigilance regulations and aggregate report formats.
Familiarity with PBRER, PSUR, DSUR, PADER, and region-specific reports (e.g., Korea PSUR).
Strong attention to detail and documentation quality.
Proficient in safety data verification and formatting consistency.
Perks & Benefits
Opportunity to work with a global pharmaceutical leader
Exposure to end-to-end aggregate safety reporting processes
Career development in a high-compliance, scientific environment
Competitive compensation aligned with industry standards
Collaborative and ethics-driven workplace culture
Company Description
Amgen is a leading biotechnology company committed to serving patients by advancing science and innovation in serious illnesses. With a global presence and strong focus on safety and compliance, Amgen offers a dynamic and ethical work environment in the pharmaceutical and healthcare domain.
Work Mode: On-site (Hyderabad, India)
Experience Required: 5–9 years
Job Type: Full-time
Call-to-Action
Ready to ensure the highest standards in pharmacovigilance reporting? Apply now to be part of Amgen’s Safety QC team in Hyderabad and drive regulatory excellence in global healthcare.
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Canada |Quebec :
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Brazil | Sao paulo |Attica :
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Manila |Croatia :
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