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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