Sr. Associate Pharamocovigilance Operations
AmgenHyderabad, Telangana, India
Posted July 3, 2025
Full Time
About the Company
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes. For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads. 🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines 🔗Global Privacy Statement Directory: www.amgen.com/dp Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Job Description
The primary responsibility of this role is to perform quality control reviews of Amgen’s Periodic Aggregate Safety Reports (PASR) to ensure accuracy, consistency, and compliance with regulatory and company standards.
Requirements
- Conduct thorough quality control reviews of PBRER/PSURs, DSURs, PADER/PAERs, and other aggregate safety reports
- Verify correct incorporation of safety data, narratives, tables, and appendices
- 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 best practices for periodic safety reporting
- Contribute to the development and refinement of QC checklists, templates, and SOPs
- Track QC metrics and support continuous improvement initiatives related to safety report quality and delivery