(Senior) PV Specialist, Affiliate Safety Representative

PRIMARY FUNCTION:

Responsible to ensure that all aspects of Pharmacovigilance at the affiliate level meets AbbVie’s statutory and ethical responsibilities, and complies with local and regional PV regulations, for the applicable product portfolio.

Acts as the Affiliate’s lead for pharmacovigilance matters with the National Regulatory Agency and AbbVie PSEQ (Pharmacovigilance and Patient Safety, Epidemiology and Research & Development Quality Assurance) function.

MAIN AREAS OF RESPONSIBILITIES:

• Metrics and Oversight of the Pharmacovigilance System
• Quality Management System
• Adverse Event & Periodic Safety Reporting
• Audits and Inspections
• Partnership with business partner with possibility for identification and/or handling of safety information
• PV Training
• Legislation Intelligence
• Risk Management
• Safety Monitoring
• Launch Readiness
• PV Advocacy
• After Hours Availability & Business Continuity

AUTHORITY AND REPORTING LINES:

This position reports into the Affiliate Medical Director.

For all PV-related matters this position has additionally a dotted-line indirect reporting relationship to the EU QPPV