Pharmacovigilance Specialist - Maternity Replacement

This position is accountable for executing the day-to-day operations and compliance activities to maintain high functioning PV systems across assigned region.
Metrics and Oversight of the Pharmacovigilance System
Supports the provision of metrics that will ensure oversight of all aspects of the performance and functioning of the PV system in compliance with local regulations and internal company timelines/standards.
Quality Management System
Develops and maintains local/regional 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 PV Exception Reporting/CAPA process.
Actively assists with the business continuity plan and testing.
Develops and maintains the local PSMF in line with AbbVie’s PV system master file, when required by local/regional regulations.
ICSR Management
Records, processes, and conducts follow up and translates adverse events and other safety information from spontaneous and solicited sources.
Performs ICSR expedited reporting according to the local requirements.
Ensures local-language medical or scientific literature review.
Implements an appropriate local quality control (QC) procedure to ensure quality of information entered and reporting decisions.
Completes AE reconciliation and ensures AE identification effectiveness sampling consistent with global procedures.
Periodic Safety Reporting
Leads the preparation of periodic safety reports (e.g., PSUR)., local annexes, local variations, and translation of safety deliverable documents.
Ensures submission of periodic safety reports and ensures documentation of evidence.
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.
Partnership with business partner with possibility for identification and/or handling of safety
information
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.
PV Training
Ensures overall training compliance with corporate procedures and local PV requirements, including the maintenance of the PV Training Matrix and the development of additional PV training materials, as required.
1 year experience required within the pharmacovigilance or a related field,
Excellent command of written and spoken English; fluency in Romanian is mandatory, and proficiency in any additional language is a plus,
Effective communicator and able to work effectively in teams and a cross functional environment,
Strong commitment to compliance with relevant rules and procedures,
Effective planning and organizational skills, and the ability to complete activities with high quality,

Employment type
Full-time

Work arrangement
Hybrid