Job Summary
Amgen, a global biotechnology leader, is seeking a Periodic Report QC Reviewer for its Hyderabad, India site. This role is ideal for professionals with experience in pharmacovigilance, regulatory writing, or aggregate report quality control. You will ensure accuracy, consistency, and compliance of key safety documents like DSURs, PSURs, and PBRERs, contributing to the delivery of safe and effective therapies to patients worldwide.
Key Responsibilities
Perform quality control reviews of periodic safety reports such as DSURs, PSURs, PBRERs, PADERs, and other country-specific reports
Verify accuracy and consistency of safety data, narratives, tables, and appendices
Ensure compliance with global regulatory requirements and internal SOPs
Collaborate with Periodic Report Specialists to resolve discrepancies and meet deadlines
Maintain and improve QC processes, checklists, and SOPs
Support inspection readiness through well-documented QC practices
Monitor QC metrics and contribute to process improvement initiatives
Required Skills and Qualifications
Bachelor’s, Master’s, or Diploma in Life Sciences, Pharmacy, or a related discipline
2 to 9 years of pharmaceutical, biotech, or regulatory experience
Minimum 2 years of experience in periodic safety report QC or authoring
Familiarity with pharmacovigilance regulations, ICH-GCP, and GVP guidelines
Understanding of DSUR, PSUR, PBRER formats and safety reporting standards
Proficiency with Microsoft Office tools, Adobe Acrobat, and systems like Veeva Vault or SharePoint
Strong attention to detail, organizational, and time management skills
Ability to work cross-functionally in a global, collaborative environment
Knowledge of AI tools for QC enhancement is a plus
Perks and Benefits
Competitive base salary (aligned with industry standards)
Comprehensive Total Rewards Plan
Inclusive and science-driven workplace culture
Opportunities for career advancement and global exposure
Structured support for personal and professional development
Company Description
Amgen is a leading biotechnology company focused on discovering, developing, and delivering innovative therapies in oncology, inflammation, general medicine, and rare diseases. With a mission to serve patients worldwide, Amgen combines science, technology, and a commitment to quality to advance human health.
Work Mode
On-site – Hyderabad, Telangana, India
Call to Action
Interested in playing a key role in global drug safety and quality?
Apply today at careers.amgen.com or submit your profile on ThePharmaDaily.com to explore similar opportunities in the pharmacovigilance and medical writing domain.
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