Job Description People. Passion. Possibilities. Three words that make a world of difference. More than a job. It's a chance to make a real difference. Welcome to AbbVie As part of an international company with 50,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? You’ve come to the right place As part of the Regional Safety Operations team at the Wiesbaden site, you will be working with talented people and experienced management experts to maintain a high-functioning PV system, enhance our drug safety processes and protect patient well-being. Together, we break through – as PV Operational Associate (This role is limited to 12 months.) Make your mark: Metrics and Oversight of the Pharmacovigilance System: Supporting 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: Developing and maintaining local/regional procedures in line with corporate procedures and local requirements. Performing the impact assessment of new/updated corporate policies, process, and procedures. Actively assisting with the PV Exception Reporting/CAPA process. Actively assisting with the business continuity plan and local PV testing. Performing archiving. ICSR Management: Recording and following-up on adverse events and other safety information from spontaneous and solicited sources. Ensuring local-language medical or scientific literature review. Supporting internal reviews in the context of ICSR Management as effectiveness checks in the context of identification of safety relevant information. Ensuring 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. Audits and Inspection Management: Actively assisting in managing internal PV audits, audits of affiliate service providers/third parties and Regulatory Authority PV Inspections. Actively assisting in the development of CAPA in response to observations and the tracking actions to completion in a timely manner. PV Training: Ensuring overall training compliance with corporate procedures and local PV requirements, including maintenance of the PV Training Matrix and development of additional PV training materials, as required. Legislation Intelligence: Monitoring local (and applicable regional/area) PV-relevant hard intelligence, leading the impact assessment of them.