Periodic Report Safety QC Reviewer
Location: Hyderabad, India
Job ID: R-219720
Posted On: July 03, 2025
Work Type: On-Site | Full-Time
About Amgen:
Amgen is a pioneer in the global biotechnology industry, driven by a deep commitment to using science and innovation to transform the lives of patients worldwide. With more than four decades of leadership in medical research and development, Amgen continues to shape the future of biopharmaceuticals by focusing on life-changing therapies across oncology, inflammation, general medicine, and rare diseases.
Position Overview:
As a Periodic Report Safety QC Reviewer, you will play a key role in the quality control of Amgen’s Periodic Aggregate Safety Reports (PASRs). Your primary objective will be to ensure the accuracy, consistency, and regulatory compliance of a range of global and country-specific pharmacovigilance documents. This position is essential to maintaining the integrity of safety reporting processes and delivering high-quality outputs that align with company and global health authority expectations.
Key Responsibilities:
Perform detailed quality control (QC) reviews of PASRs such as:
Development Safety Update Reports (DSURs)
Periodic Benefit Risk Evaluation Reports (PBRERs)/Periodic Safety Update Reports (PSURs)
Periodic Adverse Drug Experience Reports (PADERs/PAERs)
Semi-Annual Safety Update Reports (SSURs)
Device PSURs
Country-specific reports (e.g., Korea PSUR, Brazil PSUR, Colombia Annual Safety Reports)
Verify:
Safety data integration, narratives, and tabular content accuracy
Alignment of data with source documents and safety databases
Formatting and structural compliance with regulatory and internal standards
Collaborate with Periodic Report Specialists to resolve discrepancies and ensure timely delivery.
Maintain up-to-date knowledge of global regulatory safety reporting requirements, especially ICH, FDA, EMA, and other local health authority guidelines.
Assist in improving and updating:
QC checklists and templates
Standard Operating Procedures (SOPs) for aggregate report QC
Track and maintain QC performance metrics and contribute to continuous quality improvement initiatives.
Basic Qualifications:
Total Experience: 5–9 years
QC Experience: Minimum 2–3 years in quality control related to pharmacovigilance or regulatory documents
Education:
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field
Preferred Competencies & Skills:
Strong knowledge of regulatory safety reporting formats and standards (e.g., DSUR, PBRER, PADER)
Familiarity with safety databases, source document verification, and data reconciliation
Attention to detail with strong analytical, review, and documentation skills
Proficient in Microsoft Office Suite, especially Word and Excel
Ability to work collaboratively and cross-functionally under strict deadlines
Effective communication and problem-solving skills
Estimated Salary: ₹12–18 LPA (based on experience and industry benchmarks)
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