Teva Senior PV Professional ICSR Quality 

Croatia, Zagreb 

993800438

• devising, executing and managing projects in accordance with defined timings and deliverables, to ensure Teva’s full oversight and governance of ICSR reports, KPIs & Metrics standards
• ensuring individual's compliance with all laws and Regulations as well as internal policies and procedures defined and KPIs related to all ICSR reports, KPIs & Metrics aspects
• contributing / supporting the generation and maintenance of Standard Operating Procedures (SOPs) and Working Instructions (WIs) to ensure optimal operational handling of ICSR reports, KPIs & Metrics
• acting (on request/as assigned) as PSO business owner for any systems or tools implemented as part of the Global PSO and S&I (Systems and Innovation) technology driven strategy
• supporting the development of an ever efficient operational business process and systems for handling of Teva ICSR reports, KPIs & Metrics
• establishing (on request/as assigned) a strong interface and defining / executing inter function policies/SOPs with all necessary PV interfacing functions (QPPV, Compliance, LSOs/Regions) as well as strong partner collaboration (licensing and service provider partners) to ensure a full oversight
• supporting any Global led guidance to world-wide LSOs with local ICSR processes and fostering greater collaboration through Working Groups, LSO Forums and other opportunities
• managing and oversee the development of suitable operational guidances and templates to facilitate appropriate and ever-efficient ICSR reports, KPIs, Reports & Metrics handling in Teva
• evaluating the effectiveness of ICSR reports, KPIs & Metrics structures and processes, and plan, design and execute changes/innovations for greatest success in alignment with the Global operating model
• developing and enhancing ICSR reports, KPIs & Metrics handling capabilities and expertise for the future
• in conjunction with the necessary interfaces procuring, developing, overseeing and maintaining a Global System for governance of ICSR reports, KPIs & Metrics worldwide
• assessing requirements for ICSR reports, KPIs & Metrics resources, equipment and systems to maximize efficiency
• working in collaboration with Systems and Innovation group to develop ICSR compliance reports
• producing, analyzing and executing report from QlikSense, COGNOS or any other report generation system
• interfacing activities with QPPV office and Compliance i.e. Agreements (Third party alliance; Agreements Team for ICSR exchange methodology/timelines) and Compliance standards
• supporting with onboarding and ongoing training aspects needed within the reports, KPIs and Metrics team

• Master's degree in Life Sciences or another related field
• Relevant work experience in Biopharmaceutical / CRO industry, including a large international organization is highly preferred
• At least 1 year of people / project leadership experience is preferred
• Experience in handling Health Authority Inspections is a plus
• Project Management experience is an advantage
• Fluent in English

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