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Amgen
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Periodic Report QC Reviewer

Periodic Report QC Reviewer

Amgen

1 - 3 years

2 - 5 Lacs

Hyderabad

Posted:1 day ago| Platform:

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Skills Required

Technical writing Analytical Pharma Clinical research Oncology Life sciences Manager Quality Control Document management Pharmacovigilance Medical writing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Let s do this. Let s change the world. The primary responsibility of this role is to perform quality control reviews of of Amgen s Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. The QC Reviewer will ensure accuracy, consistency, and compliance with regulatory and company standards. This role supports the end-to-end writing and documentation process and ensures timelines are met.

Key Responsibilities:

Conduct thorough quality control reviews of PBRER/PSURs, DSURs, PADER/PAERs, and other aggregate safety reports to ensure content accuracy, data integrity, formatting consistency, and adherence to regulatory and internal requirements.
Verify correct incorporation of safety data, narratives, tables, and appendices, ensuring alignment with source documents and databases.
Collaborate with Periodic Report Specialists to address discrepancies and ensure timely resolution of quality issues.
Maintain up-to-date knowledge of global regulatory requirements and industry standard methodologies for periodic safety reporting.
Contribute to the development and refinement of QC checklists, templates, and SOPs to ensure consistent review practices.
Track QC metrics and support continuous improvement initiatives related to safety report quality and delivery.
Responsible for performing QC reviews of periodic safety reports to ensure compliance with the style guide, templates, and contributor inputs.
Responsible for verifying content accuracy, data integrity, and consistency across all report components.
Responsible for collaborating with Periodic Report Specialist to resolve QC findings and ensure timely delivery of high-quality reports.

Inspection Readiness:

Support inspection readiness efforts by ensuring all QC activities are well-documented, traceable, and compliant with applicable regulatory requirements.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

Master s degree and 1 to 3 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR
Bachelor s degree and 3 to 5 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR
Diploma and 7 to 9 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience
Strong attention to detail with the ability to identify inconsistencies and errors in complex regulatory documents.
Proven ability to operate effectively in a collaborative environment requiring coordination, communication, and analytical judgment.
Solid understanding of pharmacovigilance principles and global regulatory requirements related to periodic aggregate reporting (e.g., PBRERs, DSURs, PADERs).
Proficiency in scientific and technical writing/editing, with an emphasis on quality control and adherence to style guides and templates.
Excellent written and verbal communication skills in English, with strong organizational and time management abilities.
Demonstrated ability to manage competing priorities and strict deadlines while maintaining high-quality standards.
Familiarity with the structure and content of safety reports and the ability to interpret and validate data inputs from multiple contributors.
Proficient in Microsoft Office tools (Word, Excel, PowerPoint), Adobe Acrobat, and document management systems (e.g., Veeva Vault, SharePoint).
Working knowledge of AI tools and prompt use is a plus, especially for enhancing QC efficiency.
Team-oriented approach with the ability to work cross-functionally to support compliance and inspection readiness efforts.

Contribution:

Ensures Amgen remains in compliance and becomes best in class with regard to periodic aggregate report processes
Implements and maintains document standards
Responsible for successful tracking of metrics, timelines, and performance indicators for PASR objectives.

Preferred Qualifications:

Health Care Professional with minimum 2 - 3 years of relevant work experience
Including 1 to 2 years of experience in periodic aggregate safety report writing

Bachelor s / Master s degree in Health/Life Sciences with minimum 2 - 3 years of
Overall 2 + years of authoring/editing experience in medical writing domain across different therapeutic areas in safety documents including Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR).
Experience in preparation of safety documents necessary for national and international regulatory submissions to the US, European Union and other regulatory agencies.
Knowledge of Pharmacovigilance regulations for Periodic Aggregate Safety Reports.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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Periodic Report QC Reviewer