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A leading pharmacovigilance service provider in Italy is seeking an experienced ICSR Team Leader. The role involves overseeing ICSR management for projects, ensuring task distribution, and maintaining efficiency through KPI management. The ideal candidate will have a life-science background and extensive pharmacovigilance experience, including a line-management role. This position promotes a supportive environment and opportunities for professional growth.
We are PrimeVigilance (part of Ergomed Group), a specialised mid‑size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first‑class support to our small to large pharmaceutical and biotechnology partners maintaining long‑lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device. We love investing in our staff by providing an excellent training and development platform. We value employee experience, well‑being and mental health and we acknowledge that a healthy work‑life balance is a critical factor for employee satisfaction and, in turn, nurtures an environment from which a high‑quality client service can be achieved. Come and join us in this exciting journey to make a positive impact on patients’ lives.
Leads the team responsible for ICSR management for a selected project or group of projects as Team Leader.
Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process.
Assures and exerts of activities leading to effective cooperation with clients in the area of ICSR Management.
Providing support to other activities undertaken by the project team on behalf of the client and the company.
Creates and maintains project specific KPIs for contracted ICSR activities (this includes optimizing procedures, trainings and any other actions to increase ICSR team efficiency).
Proposes process changes to ICSR Operational Lead.
Manages ICSR deviations with ICSR Operational Lead support.
Reviews trackers and timesheet data and ensures accuracy.
Is involved in ICSR processing and 2nd QC of cases.
Operates as the assigned team SME and supports other SMEs.
Life‑science graduate, pharmacy, nursing, or other healthcare related qualification or experience in pharmacovigilance. Extensive experience in pharmacovigilance within which demonstrated work experience in a line‑manager role.
Excellent communication (written and verbal) skills.
Organization skills, including attention to details and multitasking.
Planning and time management.
Technical skills.
Why PrimeVigilance? We prioritize diversity, equity, and inclusion by creating an equal‑opportunity workplace and a human‑centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human‑first approach. Why? Because our people are our greatest strength, leading to our continued success on improving the lives of those around us.
Training and career development opportunities internally.
Strong emphasis on personal and professional growth.
Opportunity to work with colleagues based all over the world, with English as the company language.
We look forward to welcoming your application.
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Copy of Associate Case Processing Manager Line Management position • Rome, ITALY