Amgen Hiring for Periodic Report Safety QC Reviewer in Hyderabad. Apply online for regulatory safety jobs in India at Amgen.
About Amgen
Amgen is one of the world’s leading biotechnology companies, driven by a mission to unlock the potential of biology for patients suffering from serious illnesses. With more than four decades of experience, Amgen remains a pioneer in the biotech industry, using innovation and advanced technologies to develop medicines that have transformed countless lives. Amgen Hiring for Periodic Report Safety QC Reviewer
Founded with the vision to harness science and technology to fight the world’s toughest diseases, Amgen continues to lead global research efforts in biotechnology, molecular biology, and data-driven healthcare. The company’s presence in India supports its worldwide operations through a highly skilled team that contributes to clinical research, regulatory affairs, and safety documentation. Amgen Hiring for Periodic Report Safety QC Reviewer
Amgen’s culture focuses on integrity, excellence, and collaboration. Employees are encouraged to take ownership of their work, uphold high-quality standards, and innovate continuously. For professionals passionate about pharmaceutical safety and regulatory compliance, Amgen offers a rewarding and impactful career path. Amgen Hiring for Periodic Report Safety QC Reviewer
Position Overview
Position Title: Periodic Report Safety QC Reviewer
Job ID: R-219720
Location: Hyderabad, India
Work Type: On-Site
Category: Safety
Date Posted: July 3, 2025
Amgen is inviting applications for the role of Periodic Report Safety QC Reviewer at its Hyderabad office. This position plays a critical role in ensuring the quality, consistency, and compliance of Amgen’s global periodic aggregate safety reports.
The role involves reviewing various regulatory safety reports — including Development Safety Update Reports (DSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), and other global and country-specific safety documentation — to maintain the highest standards of accuracy and compliance. Amgen Hiring for Periodic Report Safety QC Reviewer
About the Role
The Periodic Report Safety QC Reviewer will perform detailed quality control (QC) reviews of Amgen’s periodic safety reports to ensure all documents are accurate, consistent, and aligned with regulatory and internal requirements. Amgen Hiring for Periodic Report Safety QC Reviewer
This position requires a strong understanding of regulatory documentation, pharmacovigilance processes, and global safety standards. The QC Reviewer supports the end-to-end documentation process by ensuring that all deliverables meet compliance expectations, follow proper formatting and style, and adhere to timelines.
This role also involves collaboration with the Periodic Report Specialists and other stakeholders to identify discrepancies, resolve quality issues, and ensure high-quality submission of reports to global regulatory authorities. Amgen Hiring for Periodic Report Safety QC Reviewer
Key Responsibilities
As a Periodic Report Safety QC Reviewer, you will be responsible for a wide range of tasks that ensure Amgen’s safety reports meet global compliance and quality standards. Key responsibilities include: Amgen Hiring for Periodic Report Safety QC Reviewer
- Conduct Quality Control Reviews
- Perform in-depth QC reviews of PBRERs/PSURs, DSURs, PADERs/PAERs, and other periodic safety reports.
- Ensure that the content is accurate, data is consistent, and formatting aligns with regulatory and Amgen’s internal requirements.
- Ensure Data Accuracy and Integrity
- Verify the correct incorporation of safety data, narratives, tables, and appendices.
- Cross-check report content with source data and reference databases to confirm accuracy and completeness.
- Collaborate with Periodic Report Specialists
- Work closely with report authors and safety teams to identify and resolve discrepancies.
- Provide feedback and recommendations to ensure reports meet the highest quality standards.
- Stay Updated with Global Regulations
- Maintain comprehensive knowledge of global pharmacovigilance regulations and industry best practices in periodic safety reporting.
- Apply current guidelines from agencies such as the FDA, EMA, and ICH to ensure regulatory compliance.
- Develop and Improve Review Processes
- Contribute to the enhancement of QC templates, checklists, and SOPs for standardization and continuous process improvement.
- Help train team members on updated QC practices and documentation standards.
- Track and Analyze Quality Metrics
- Monitor QC performance metrics and participate in continuous improvement initiatives.
- Support data-driven improvements to enhance report quality and timeliness.
Reports Covered
The QC Reviewer will handle a wide range of Periodic Aggregate Safety Reports (PASRs), including but not limited to:
- Development Safety Update Reports (DSURs)
- Periodic Benefit-Risk Evaluation Reports (PBRERs) / Periodic Safety Update Reports (PSURs)
- Semi-Annual Safety Update Reports (SSURs)
- Periodic Adverse Drug Experience Reports (PADERs/PAERs)
- Device PSURs
- Country-Specific Reports, such as:
- Korea PSUR
- Brazil PSUR
- Colombia Clinical Research Annual Safety Report Submission and Evaluation Form
This diversity of reports ensures exposure to multiple regulatory frameworks, making this an ideal opportunity for professionals aiming to expand their expertise in global pharmacovigilance compliance. Amgen Hiring for Periodic Report Safety QC Reviewer
Required Experience and Qualifications
Basic Qualifications
- Education: Bachelor’s or Master’s degree in Life Sciences or Pharmacy.
- Experience: Minimum of 5 to 9 years of total experience, including 2–3 years specifically in Quality Control (QC) within a regulatory, pharmacovigilance, or clinical documentation setting.
- Skills:
- Strong analytical ability to interpret scientific and safety data.
- Meticulous attention to detail and accuracy.
- Proficiency in MS Office tools and familiarity with document management systems.
- Excellent written and verbal communication skills in English.
- Strong organizational and time-management skills with the ability to handle multiple tasks simultaneously.
- Proven track record of working under strict regulatory timelines.
Preferred Qualifications
While not mandatory, candidates with the following additional skills and experiences will be preferred: Amgen Hiring for Periodic Report Safety QC Reviewer
- Familiarity with international safety databases and clinical trial documentation systems.
- Experience reviewing pharmacovigilance reports and working in global regulatory environments.
- Knowledge of Good Pharmacovigilance Practices (GVP) and ICH E2C(R2) guidelines.
- Previous experience in a biotechnology or pharmaceutical company with global regulatory submissions.
- Demonstrated ability to collaborate effectively across global teams and manage cross-functional communication.
Why Join Amgen?
Working at Amgen means being part of a company that values people, innovation, and science. You will join a diverse team of talented professionals committed to making a positive impact on global healthcare. Amgen Hiring for Periodic Report Safety QC Reviewer
At Amgen, employees are encouraged to think creatively, share ideas, and contribute to solutions that matter. The company provides a professional environment that promotes career growth, learning opportunities, and work-life balance.
As part of Amgen’s Hyderabad team, you will work alongside global experts in pharmacovigilance, clinical research, and regulatory writing, gaining invaluable exposure to international reporting standards and high-impact projects. Amgen Hiring for Periodic Report Safety QC Reviewer
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer. The company does not discriminate against any applicant or employee based on race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, or veteran status. Amgen Hiring for Periodic Report Safety QC Reviewer
Amgen ensures that individuals with disabilities are provided reasonable accommodations during the recruitment process and throughout employment to support their success and participation in all aspects of work life. Amgen Hiring for Periodic Report Safety QC Reviewer
Work Location
- City: Hyderabad, India
- Work Type: On-Site
- Category: Safety
- Job ID: R-219720
Amgen’s Hyderabad facility offers a collaborative workspace, advanced tools, and opportunities for professional growth. The on-site work culture fosters teamwork, innovation, and communication across departments. Amgen Hiring for Periodic Report Safety QC Reviewer
How to Apply
If you are ready to advance your career in pharmacovigilance and regulatory quality control, Amgen invites you to apply for the Periodic Report Safety QC Reviewer position.
Follow these steps to apply:
- Visit the official Amgen careers portal: https://careers.amgen.com
- In the search bar, enter Job ID: R-219720 or search for “Periodic Report Safety QC Reviewer – Hyderabad.”
- Review the full job details and confirm your eligibility.
- Click on the “Apply Now” button.
- Log in with your Amgen Careers account or create a new one.
- Fill out the application form, upload your resume, and submit your application.
Amgen encourages qualified professionals to apply early to ensure consideration for this opportunity.
Conclusion
The Periodic Report Safety QC Reviewer role at Amgen India, Hyderabad, offers a unique opportunity to be part of a world-class biopharmaceutical organization. This position is ideal for professionals with a strong background in regulatory quality control, pharmacovigilance documentation, and data verification. Amgen Hiring for Periodic Report Safety QC Reviewer
If you are detail-oriented, passionate about ensuring regulatory compliance, and eager to contribute to Amgen’s global mission of improving patient health, this role could be the perfect step forward in your career. Apply now and become part of a team that’s redefining biotechnology innovation worldwide. Amgen Hiring for Periodic Report Safety QC Reviewer
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