Sara Cintura

Develop scientific and medical content in Italian for promotional materials supporting a haematology product, ensuring alignment with client requirements and applicable regulatory standards and delivery within tight timelines

Developed promotional and non-promotional materials; Developed and implemented the local launch campaign for a new indication in metastatic breast cancer (mBC); Led the materials workstream within the operational task force for the European Breast Cancer Conference (EBCC) in Milan (2024); ndependently managed Continuing Medical Education (CME) sponsorships on behalf of the Marketing team; Active contributor to cross-functional AI initiatives

Managed regulatory lifecycle of assigned products (Ambisome, Trodelvy, Zydelig, Cayston) across centrally and nationally authorized products; Conducted compliance reviews of promotional and non-promotional materials; Contributed to Quality Management System activities; Conducted training sessions for internal teams on regulatory requirements and compliance

Appointed as Deputy Local Contact Point for Pharmacovigilance in 2015 and managed end-to-end local pharmacovigilance activities; Led affiliate preparation and coordination for internal Global Quality audit; Managed regulatory lifecycle activities (variations, renewals, commercial launch, product information and labelling updates); Performed regulatory compliance review of promotional and non-promotional assets; Handled deviations, CAPA, and product complaints and change control;

Performed Level 2 Global Quality Audit preparation checks on five years of historical safety information, covering approximately 5,000 ICSRs/year, including duplicate checks and verification of routing and reporting; identified data quality issues, raised correction requests with the data entry team, and followed up on agreed corrective actions to ensure timely resolution; Processed safety information intakes and follow-up activities in compliance with local and GVP requirements and company procedures.