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 (https://www.tiktok.com/@abbvie) . Job Description Responsible to ensure that all aspects of Pharmacovigilance at the affiliate level meets AbbVie’s statutory and ethical responsibilities, and complies with local and regional PV regulations, for the applicable product portfolio. Acts as the Affiliate’s lead for pharmacovigilance matters with the National Regulatory Agency and AbbVie PSEQ (Pharmacovigilance and Patient Safety, Epidemiology and Research & Development Quality Assurance) function (in case of absence of the ASR) Serves as the local Qualified Person for Pharmacovigilance (QPPV), with sufficient authority to influence the performance of the quality system and pharmacovigilance activities and to promote, maintain and improve compliance with the legal requirements Provide data-driven insights and project management support by analyzing data, managing dashboards, and ensuring the successful execution of medical department initiatives. Responsabilities: Oversight of the Pharmacovigilance System + Ensures that PV processes, procedures and systems are in place to comply with AbbVie Global PV procedures and with local and/or regional PV regulations. + Maintains oversight of the performance of all activities that fulfil local and applicable regional PV regulations, including those performed by PSEQ Regional PV Teams and/or outsourced partners. + Delegates specific tasks under supervision and with documentation, to appropriately qualified and trained individuals, provided that the QPPV/QPPV Back-up maintains system oversight and overview of the safety profiles of all products. Quality Management System + Partners with PSEQ Regional PV Teams to: + Ensure Affiliate PV System procedure(s) aligns with corporate PV procedures and complies with local and regional PV regulations. + Manage any non-conformity and/or planned departures from corporate and/or local PV procedures according to the global issue and exception management process and ensure any corrective/preventive actions are completed according to the schedule. + Maintain oversight of the PV training plan and ensure training compliance of local PV personnel and other affiliate personnel with Corporate and Local PV training requirements. + Oversee training compliance of partner company staff according to local contract requirements. Adverse Event & Periodic Safety Reporting + Maintains oversight of the PV system and ensures that processes, procedures and systems are in place for intake, processing, conducting follow up, translating and reconciling adverse events and other safety information reportable to PPS from spontaneous and solicited sources and from clinical studies. + Partners with Regional PV Teams in PSEQ to ensure reporting of both clinical and post-marketing Individual Case Safety Reports (ICSRs) and Periodic and Aggregate Reports to the Regulatory Agency, Ethics Committees and Investigators, to comply with corporate PV procedures and with local and regional PV regulations as required. Audits and Inspections + Affiliate Lead and point of contact (in case of absence of the ASR) for affiliate PV audits and Regulatory Authority PV inspections, demonstrating understanding of the overall AbbVie PV system and how Global PV processes and PSEQ Regional PV Teams are set-up and structured, supporting the fulfilment of local legal requirements. + Collaborates with PSEQ Regional teams in managing audits of processes executed by the PSEQ Regional PV Teams and audits of affiliate service providers/third parties. + Supports PSEQ Regional teams 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 + Acts as key safety advisor for affiliate cross-functional partners on safety topics to address business needs and ensure that business partnerships involving activities where there is a reasonable possibility for the identification and/or handling of safety information are assessed for the generation of safety information and the applicable PV requirements, and that applicable PV and safety data exchange agreements are implemented. Qualifications + Medical, pharmacy or life-sciences degree (or equivalent) + At least two years’ experience working in the pharmaceutical industry in a pharmacovigilance role is required. + Adequate theoretical knowledge and practical experience of PV activities and system under purview (as stipulated in local guidance) and sound understanding of the regulatory and PV monitoring requirements for assigned territory(ies) that comply with any specific training requirements mandated by relevant regulatory agencies. + Excellent written and spoken communication and presentation skills. + Fluency in written and oral English is essential to facilitate communications with PSEQ, Area/Regional Medical and other headquarters functions. + Fluency in written and oral local language is a requirement to facilitate communications within the affiliate medical department, and with the National Regulatory Agency. + High customer orientation. + Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity. + Sound judgment, strong planning and organizational skills, and the ability to get things done. + Demonstrated strong sense of urgency. 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. 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