Company Description

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.

Job Description

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.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

Establishes standards and oversees the monitoring of outsourced processes, investigates and leads the follow-up of discrepancies.Leads 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.Presents results of quality control 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. Leads 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 and reliable documents resultsProactively leads the identification of areas of process and technical improvement and leads the implementation of changes. Refines and adapts 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.
Qualifications

 

Bachelor’s Degree or equivalent in related science field4 years pharmaceutical industry experience; including a minimum of 3 years in pharmacovigilance quality systems. Affiliate experience strongly preferredVery good knowledge of global pharmacovigilance regulations, including one or more countries with an excellent understanding of PV quality assurance systemsSkilled at technical writing and authoring, including SOPs/procedural documents, corrective actions plans / exception reportsHighly skilled in data interrogation and interpretation; highly experienced with using complex models and excelGood influencer across multiple stakeholders and manage within an affiliate matrix; seen as a collaborative partner at all levels of the organizationProven track record of proactively identify, assess, and effectively manage compliance risksExperienced in working in cross-functional teams or global projects Highly analytical with excellent attention to detailExcellent written and spoken English plus highly skilled in at least one other language
Additional Information

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

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html