Global Pharmacovigilance Medical Safety Writer - Temporary Department: Global Regulatory Affairs & Patient Safety Business Area: R&D;, Pharmacovigilance & Regulatory Affairs Job Type: Direct Employee Contract Type: Temporary Location: Parma, IT This is what you will do You will be responsible for the following: Support the Coordinator in the global planning (for both molecules under development and those with a Marketing Authorisation). Write, consolidate, update and distribute aggregates for global products with the cross‐functional team. Submit aggregate reports to Health Authorities where applicable. Monitor compliance for PSURs/PBRERs and DSURs submitted for global products/molecules under development. Serve as QC responsible for aggregate reports and global planning. Lead the process/project for cross‐functional working teams. Manage related Health Authority assessments (e.g., "requests for supplementary information" – RSI). Support Safety Physicians in writing the relevant sections of renewal documents (Addendum to Clinical Overviews – ACOs)



for global products and provide support during RSI in the renewal procedure. Assist the Coordinator in calculating quality aggregate KPIs as QC responsible. Align risk‐management materials with current approved documents (PBRER, ACO, PADER, RMP, presentations, signal evaluations). Produce high‐quality, accurate and fit‐for‐purpose documents with clear conclusions. Communicate technical, medical, and scientific information in critical submission and internal PV documents, ensuring timely delivery. Collaborate cross‐functionally to continuously improve standards and best practices for medical writing. Upload pharmacovigilance documents for global products in the EDMS via appropriate workflows. Monitor aggregate inbox and HA websites, including CTIS, and share results (e.g., EURD list, ASR RFI) with relevant stakeholders. Represent the MSW part in audits and inspections. Support QPO in compliance calculations related to PSURs/

📌 Global pharmacovigilance medical safety writer (Italia)
🏢 Chiesi Farmaceutici
📍 Italia