Assistant Director, Affiliate PV Partner Compliance

The purpose of this role is to establish and maintain effective oversight and invoicing controls of external providers of pharmacovigilance services for AbbVie affiliates. At minimum external providers 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 AbbVie products.

Responsibilities

1. Owns the monitoring of supplier performance via SLAs and other metrics, prepares routine and ad hoc reports, owns the investigation of trends, and escalates issues as appropriate.
2. Oversees quality control (QC) of all outsourced processes and reliable documents results. Refines and adapts QC approaches to account for external and internal process, regulatory and business change.
3. Owns issue investigation ( eg CAPAs), coordinating between AbbVie teams 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.
4. Collaborate with suppliers and internal partners to implement vendor compliance management processes which integrate with supplier and AbbVie processes wherever possible. Support the use of risk-proportionate approaches for in-line and retrospective evaluations.
5. Owns the managing and tracking (actuals vs. forecast) of all invoicing activities for all outsourced PV affiliate activities for each affiliate worldwide.
6. 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.
7. Owns the development of training plans and supports delivery of training sessions (through multiple modalities) in conjunction with supplier, including train-the-trainer, special-topics, refresher, and internal AbbVie trainings as needed.
8. Supports internal/third-party audits and health authority inspections of supplier services or AbbVie oversight. Works with supplier to ensure continual inspection readiness including procedural documentation, records, and inspection training.
9. Presents compliance results to senior, cross-functional AbbVie stakeholders. Participates in supplier management and governance meetings, and maintains strong working relationship with colleagues in PPS, RDQA, and Affiliate PV & Quality organizations.
10. Responsible as a senior member of the Affiliate PV Operations team for driving compliance and business excellence for all of outsourced affiliate PV activities.

• Bachelor's Degree or equivalent in related science field
• 5-7 years pharmaceutical industry experience; including a minimum of 5 years in pharmacovigilance, vendor management and/or training operations. Affiliate experience strongly preferred
• Strong knowledge of global pharmacovigilance requirements, including regulations and affiliate environment, with a firm understanding of related quality assurance systems
• Experience in health authority inspections and/or internal or third-party audits
• Highly skilled in data interrogation and interpretation; highly experienced with using complex models and excel
• Able to influence across multiple stakeholders and manage within a cross-functional matrix; seen as a collaborative partner at all levels of the organization
• Able to proactively identify, rapidly assess, and effectively manage business and compliance risks
• Strong end to end knowledge of outsourced PV processes, invoice management and working with Vendor's supplying global pharmacovigilance services
• Proven track record of managing Vendor invoicing activities (>USD$ 1MM per annum)

Travel expectations: 6-10 ex-country trips annually, including vendor offshore locations