Work as Pharmacovigilance Operations Senior Associate at Amgen

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 discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

Post : Sr Assoc Pharmacovigilance Operations

Job Description
• Support vendor oversight of all case intake and processing activities
• Case review
• Escalation of case level issues
• Support convention-related training delivery
• Manage queries on Intake, triage, and data entry of ICSRs
• Reporting decision for submitting all expedited safety reports to FDA/EMA
• Ensuring that individual ICSRs are evaluated for reporting in compliance with regulations and contracts
• Reporting of ICSRs within time frames determined by regulations and contracts
• Support BP reconciliation as required by safety agreement
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Be representative for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
• Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor.

Key Activities
• Support ICSR processing to ensure high-quality cases in a timely manner to meet all worldwide regulatory authority requirements
• Perform case review
• Perform US case follow up activities
• Support the development and delivery of convention-related training material
• Review and respond to AE intake, triage, and submission queries in a timely fashion
• Initiate unblinding as requested
• Select cases for reporting to FDA/EMA and business partners based on detailed knowledge of legislation & contractual agreements
• Ensure compliance of reporting activities with timelines and criteria
• Interface with local office staff, vendors, and business partners for case processing as necessary
• Escalation of data entry issues identified
• Provide LAO E2B support (nullification, redistribution)
• Perform BP reconciliation as required by safety agreement
• Support the ICSR literature review process
• Support reportable event reconciliation for Amgen-sponsored clinical trials.
• Support other case processing functions as required.

Candidate Profile
Bachelor’s degree and 2 years of directly related experience
OR
Associate’s degree and 6 years of directly related experience
OR
High school diploma / GED and 8 years of directly related experience

Knowledge and Skills
• Understanding of global regulatory requirements for pharmacovigilance
• Familiarity with clinical development process
• Case processing experience with demonstrated high case level productivity and quality
• Attention to detail
• Proficiency in safety system
• Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook

Additional Information
Experience : 2-8 years
Qualification : Bachelor’s degree
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Safety
End Date : 20th September 2026