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

Support the establishment and maintenance of effective compliance & oversight of external providers of pharmacovigilance services for AbbVie affiliates. At a minimum this system must ensure compliance with global regulatory requirements, AbbVie standards and local PV regulations. The scope extends to all externalized services and providers overseen by PPS on behalf of AbbVie affiliates, including adverse event management, reporting, and related operational activities, and spans all marketed products.

Responsibilities

• Manages standards and oversees the monitoring of outsourced processes, investigates and leads the follow-up of discrepancies.
• Manages the monitoring of supplier performance via SLAs and other metrics, prepares routine and ad hoc reports, leads the investigation of trends, and escalates issues as appropriate.
• Supports presentations of quality control results and trend analysis to senior, cross-functional AbbVie stakeholders.
• Support the establishment of AbbVie quality management processes for external suppliers of affiliate pharmacovigilance services that meet applicable PPS, RDQA, and affiliate standards and ensure reproducible, controlled, and timely delivery of high quality outputs.
• Collaborate with suppliers and internal partners to implement vendor quality management processes which integrate with supplier and AbbVie processes wherever possible. Support the use of risk-proportionate approaches for in-line and retrospective evaluations.
• Supports development of materials and delivers training sessions (through multiple modalities) in conjunction with supplier, including train-the-trainer, special-topics, refresher, and internal AbbVie trainings as needed.
• Manages issue investigation (eg CAPAs), coordinating between AbbVie and supplier systems. Supports the communication and collaborates across internal and partner stakeholders for prioritization of issues, as well as timely, effective, and permanent remediation actions.
• Performs quality control (QC) of all outsourced processes reliable documents results; proactively identifies areas of process and technical improvement and supports the implementation of changes.
• Proactively suggests changes in QC approaches to account for external and internal process, regulatory and business change.
• Responsible as a member of the Affiliate PV Operations team for driving compliance and business excellence for all of outsourced affiliate PV activities.

Please note - candidates who are not fluent in Spanish cannot be considered for this role.

Qualifications

List required and preferred qualifications (up to 10). Include education, skills and experience.

• Bachelor’s Degree or equivalent in related science field
• 3 years pharmaceutical industry experience; including a minimum of 2 years in pharmacovigilance quality systems. Affiliate experience strongly preferred
• Good knowledge of global pharmacovigilance regulations, including one or more countries with an excellent understanding of PV quality assurance systems
• Skilled at technical writing and authoring, including SOPs/procedural documents, corrective actions plans / exception reports
• Good Excel, data interrogation and interpretation skills and experience
• Good influencer across multiple stakeholders; seen as a collaborative partner across the organization
• Able to proactively identify, assess, and effectively manage compliance risks
• Experienced in working in cross-functional teams
• Analytical with a high degree of attention to detail
• Very good written and spoken English plus one other language

Key Stakeholders 

• PPS: Safety Compliance, Affiliate Vigilance Excellence, Vendor Management Team, Case Processing Center of Excellence, ODC Center of Excellence, EU QPPV. RDQA: Pharmacovigilance & Regulatory Affairs Quality Assurance. GMA: Area Medical Heads, Aff MD's

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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