Sr Assoc Pharmacovigilance Operations

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