Sr. Associate Pharmacovigilance 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
This position plays a role in authoring, compilation and peer review of Amgen's Periodic Aggregate Safety Reports (PASR) and other reports in compliance with global regulatory requirements.
Requirements
- Compilation and authoring of PASRs
- Coordinate and schedule meetings with cross-functional stakeholders
- Drive report timelines and escalate risks or delays
- Collaborate with cross-functional stakeholders and external business partners
- Conduct peer QC of safety authored sections
- Maintain and archive accurate records and documentation
- Review and approve published report versions
- Manage report distribution to Contract Research Organizations (CROs) and Business Partners (BPs)
- Peer review/quality review of all PASRs
- Maintain and develop current knowledge of regulatory guidelines, technological advances and industry standards
- Generate PASR metrics, including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs)