PV Operational Associate

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Purpose:
This position is accountable for executing the day-to-day operations and compliance activities to maintain high-functioning PV systems across the assigned region remit. It reports directly to the PV Operational Team Lead.

Responsibilities:

• Metrics and Oversight of the Pharmacovigilance System: Support the provision of metrics to ensure oversight of PV system performance and compliance.
• Quality Management System: Develop and maintain local/regional procedures in line with corporate and local requirements. Perform impact assessments of new/updated corporate policies. Assist with the PV Exception Reporting/CAPA process, business continuity plan, and local PSMF development.
• ICSR Management: Record, process, conduct follow-up, and translate adverse events. Ensure local-language literature review and implement local QC procedures. Complete AE reconciliation consistent with global procedures.
• Periodic Safety Reporting: Lead preparation and ensure submission of clinical periodic safety reports.
• Audits and Inspection Management: Assist in managing internal PV audits, audits of affiliates, and regulatory inspections. Develop CAPA in response to observations.
• Partnership with Business Partner: Ensure PV requirements are in place for safety information handling.
• PV Training: Ensure training compliance with corporate and local PV requirements.
• Legislation Intelligence: Monitor and assess local PV-relevant hard intelligence.
• After Hours Availability & Business Continuity: Ensure 24-hour availability for AE reporting and have a Disaster Recovery Plan.

Qualifications:

• A minimum of 3 years of experience required within pharmacovigilance or a related field.
• Effective communicator, able to work in teams and a cross-functional environment.
• Strong commitment to compliance with relevant rules and procedures.
• Effective planning and organizational skills, with the ability to complete activities with high quality.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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