Sr Assoc Pharmacovigilance Operations

Group Purpose

• Act as US/EU local safety office and FDA/EMA point of contact for safety reporting
• Submission of all individual case safety reports to FDA/EMA/BPs
• Support interactions with business partners (license partners) and vendors for all case intake and processing activities
• Vendor oversight of all case processing activities and case quality including analysis and reporting of trends in quality measures
• Ensure vendor compliance with approved processes and training requirements
• Audit & external inspection support

Job Summary

Responsible for:

• Support reportable event reconciliation for Amgen sponsored clinical trials
• 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

• Reportable event reconciliation: Perform review of non-matching safety data in clinical and safety databases
• Oversee/manage vendor clinical safety reconciliation team(s)
• 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 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