Sr Assoc Pharmacovigilance Operations

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

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