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
