**Job Summary** **Responsible for:** + 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. 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 Education & Experience (Basic) **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**

📌 Sr Assoc Pharmacovigilance Operations (Hyderabad)
🏢 AMGEN
📍 Hyderabad