Company Description
This position is accountable for executing the day-to-day operations and compliance activities to maintain high-functioning PV systems across assigned region remit. Works closely with the local PV contact person. Reports to the Regional PV Lead.
Job Description
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.ICSR Management
Supervise records, processes, and conducts follow up and translates adverse events and other safety information from spontaneous and solicited sources.
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
Ensures submission of periodic safety reports and ensures documentation of evidence.Audits and Inspection Management
Actively assists in 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.Legislation Intelligence
Monitors local (and applicable regional/area) PV-relevant hard intelligence, leading the impact assessment of them.Risk Management
For Individuals supporting Risk Management activities:Coordinates the receipt and distribution of RMP, Core Implementation Plan (CIP) and additional risk minimization measures (aRMM) to affiliate stakeholders.Develops a deep knowledge of the Risk Management Plans (RMPs) to obtain information on the risk/benefit profile of products. Liaises with affiliate stakeholders & Benefit Risk Management (BRM) Team and where applicable, seek involvement of relevant PSEQ stakeholders during development or revision of the COUNTRY Specific Annex (if applicable), Local Implementation Plan (LIP) & local aRMM. Performs the assessment and implementation of the CIP and accompanying aRMM, when applicable
Qualifications
A minimum of 4 years experience required within the pharmacovigilance or a related fieldEffective 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. Advance level of english and spanish written and spokenBased in Madrid.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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