Job Summary
Amgen is hiring a Periodic Report QC Reviewer for its Hyderabad location. This vital role focuses on the quality control review of Periodic Aggregate Safety Reports (PASR), including DSURs, PBRERs/PSURs, PADER/PAERs, and other country-specific reports. The ideal candidate will ensure compliance, data accuracy, and consistency of global pharmacovigilance documents, supporting Amgen's dedication to safety and regulatory excellence.
Key Responsibilities
Perform quality control reviews of various periodic aggregate safety reports (e.g., PBRERs, DSURs, PADER/PAERs).
Verify data accuracy, formatting consistency, and alignment with source documents.
Collaborate with Periodic Report Specialists to resolve discrepancies.
Maintain and update QC checklists, SOPs, and templates.
Track QC metrics and contribute to continuous process improvement.
Ensure documentation supports inspection readiness and regulatory compliance.
Support the development and implementation of document standards.
Monitor and report on PASR metrics, timelines, and key performance indicators.
Required Skills & Qualifications
Education:
Master’s with 1–3 years OR
Bachelor’s with 3–5 years OR
Diploma with 7–9 years in pharmaceutical, biotech, or regulatory fields.
Must-Have Skills:
Strong knowledge of pharmacovigilance principles and global regulations (e.g., PBRER, DSUR, PADER).
Expertise in scientific/technical writing and document QC processes.
Proficiency in Microsoft Office (Word, Excel, PowerPoint) and document management tools (Veeva Vault, SharePoint).
Detail-oriented with excellent analytical skills to detect document inconsistencies.
Strong verbal and written communication in English.
Preferred Skills:
2–3 years in aggregate safety report writing.
Experience preparing safety documents for international regulatory submissions.
Familiarity with AI tools for enhancing QC processes.
Working knowledge of pharmacovigilance databases and safety reporting structures.
Perks & Benefits
Competitive salary and industry-aligned Total Rewards Plans.
Opportunities for growth in a global pharmacovigilance environment.
Collaborative and innovative work culture.
Exposure to international regulatory compliance processes.
Continuous professional development and learning.
Company Description
Amgen is a world-leading biotechnology company dedicated to improving patient outcomes through innovation in biologics and pharmaceuticals. With expertise in oncology, inflammation, general medicine, and rare diseases, Amgen delivers therapies that make a real difference in patients' lives.
Work Mode
On-site (Hyderabad, India)
Salary/Compensation
Not disclosed in the job description.
Call to Action
If you possess a keen eye for detail and a passion for ensuring quality and compliance in pharmacovigilance documentation, apply now to become part of Amgen’s mission to advance global patient safety.
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