Sr Assoc Pharmacovigilance Operations

Job description

Career Category Safety Job Description 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 .