Senior PV Operations Specialist

The Senior PV Operations Specialist will have oversight and management of UK PV operational systems with a strong commitment to compliance with relevant AbbVie requirements, European and local legal obligations. This role supports the development of local processes that clearly define the pharmacovigilance responsibilities and requirements within the affiliate in line with all applicable AbbVie Standard Operations Procedures and processes, the Code of Conduct and the local legislation. In this role you will be responsible for oversight and management of critical UK PV system compliance including aggregate reporting, UK PSMF and PV Partnerships activities., ICSR Management:

• Oversight and management of the UK PV intake system which includes email, telephone and website interactions and timely ICSR communication to Third Party case processor. Responsible for follow up of ICSRs where Third Party case processor is unable to directly follow-up.
• Oversight and maintenance of UK PV dashboards to include escalation and investigation of non-compliance to Global teams and UK QPPV.
• Where delegated, is a point of contact for communication with regulatory authorities on drug safety issues and ensures that all regulatory authority communications are forwarded, as required, to the UK QPPV and necessary PSEQ personnel.
• Creates periodic compliance reports, reporting relevant compliance metrics to UK QPPV, AMD and PSEQ leadership and follows up the results to ensure robust documentation.
• Regularly researches national regulations and laws, forwarding notifications of new regulations to UK ASR and other Global functions as required
• Completes AE reconciliation and ensures AE identification effectiveness sampling consistent with global procedures.
UK PSMF Activities:
• Responsible for monthly updates to the core UK PSMF and alignment with EU changes.
• When delegated, responsible for the creation and maintenance of annexes related to UK PV system compliance, training and issue management processes.
• Actively assists in the periodic creation of the UK PSMF as a complete document including annex 'I' creation.
Quality Management System:
• Develops and maintains local procedures in line with corporate procedures and local requirements.
• Performs the impact assessment of new/updated corporate policies, process, and procedures.
• Actively assists with the local PV Exception Reporting/CAPA process.
• Actively assists with the business continuity plan and testing.
Audits and Inspection Management:
• Actively assists in managing internal PV audits, audits of affiliate service providers/third parties and Regulatory Authority PV Inspections.
• Actively assists in the development of CAPA in response to observations and the tracking actions to completion in a timely manner.
Training:
• Supports the ASR and PSEQ Regional PV Teams in ensuring overall training compliance with corporate procedures and local PV requirements.
• Where delegated, has responsibility to maintain the version-controlled training matrix for local pharmacovigilance employees and supports the annual review process.
• Leads the creation of pharmacovigilance (PV) training materials and oversees the conduct of PV training measures for employees within the Pharmacovigilance Department, other departments within AbbVie UK as well as external cooperation partners including success checks of PV training measures.
• Responsible for periodic reporting of relevant training metrics to ASR/AMD and other functions when required.
Periodic Reports:
• Leads the preparation of periodic safety reports (e.g. PSUR, DSUR), local annexes, local variations, and safety deliverable documents.
• Ensures submission of periodic safety reports and ensures documentation of evidence.
PV Partnerships and PV Agreements:
• Ensures all PV requirements are in place for activities where there is a reasonable possibility for the identification and/or handling of safety information in accordance with AbbVie procedures and local requirements.