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

.