Senior Affiliate PV Partner Compliance Specialist

AbbVie’s mission is to discover and deliver innovative medicines 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.

Our Affiliate Pharmacovigilance (PV) Partner Compliance team operates on a global scale, spanning the US, Canada, UK, Netherlands, Argentina, Brazil, Germany, Romania, and beyond. Join us in making a remarkable impact across multiple therapeutic areas in the position Senior Affiliate PV Partner Compliance Specialist.

Reporting to our Associate Director, Global Safety Operations you will support the establishment and maintenance of effective compliance and oversight for external providers of pharmacovigilance (PV) services for AbbVie affiliates. In addition, you ensure all activities meet global regulatory standards, AbbVie policies, and local PV regulations. You will oversee outsourced services and vendors, including adverse event management, reporting, and related processes for all marketed products.

Key Responsibilities:

• Establish and monitor standards for outsourced PV activities; investigate and lead follow-ups on process discrepancies
• Lead monitoring of supplier performance, analyze SLAs and metrics; prepare routine/ad hoc reports and investigate trends, escalating issues as needed
• Present quality control and trend analysis to senior cross-functional stakeholders
• Support and implement AbbVie quality management systems for external PV suppliers, ensuring consistent delivery of high-quality outputs
• Collaborate with suppliers and internal teams to integrate vendor quality management processes
• Develop and deliver compliance training, including train-the-trainer and refresher sessions, as well as internal and external education
• Lead investigation of CAPAs and coordinate issue resolution and remediation actions across stakeholders
• Perform, document, and improve quality control on outsourced processes
• Proactively drive improvements in compliance and QC approaches adapting to regulatory and business changes
• Play an active role within the Affiliate PV Operations team to drive compliance and business excellence in all outsourced affiliate PV activities

We are seeking a person who has the following skills and experience:

• Bachelor’s Degree (or equivalent) in a science-related field (required)
• Minimum 4 years pharmaceutical industry experience or, including at least 3 years in pharmacovigilance quality systems; alternatively experience in a pharmacovigilance position in a CRO
• Affiliate PV experience desirable
• Very good knowledge of global pharmacovigilance regulations and PV quality assurance systems
• Skilled technical writer with experience in SOPs, procedural documents, CAPAs/exception reports
• High-level skills in data interrogation, analysis, and advanced Excel use
• Excellent influencing and communication skills, able to manage stakeholders and collaborate in a matrix/global environment
• Strong track record of proactive compliance risk management
• Highly analytical with meticulous attention to detail
• Fluent in English and Spanish; proficiency in at least one additional language is highly valued (preferred; French, German, Dutch, Portuguese advantageous)

Joining AbbVie means you will be part of a team of outstanding professionals dedicated to making a remarkable impact on patients' lives. At AbbVie, we conduct ground-breaking science on a global scale every day.

This is a hybrid position with ideal location Bucharest however, we are open to consider applicants from other locations.

To apply for this position please submit a CV at your earliest convenience.  Applications will close on the 4.12.25. 

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. 

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