Ph3Global Pharmacovigilance Medical Safety Writer - Temporary /h3 pDate: 28 Apr 2026 /p pDepartment: Global Regulatory Affairs Patient Safety /p pBusiness Area: RD, Pharmacovigilance Regulatory Affairs /p pJob Type: Direct Employee /p pContract Type: Temporary /p pLocation: Italy (Parma) with possibility of smart working /p h3What you will do /h3 ul liProcess owner (cross-functional) for developing a wide range of pharmacovigilance documents for the assigned global products within the specific therapeutic area, including Periodic Safety Reports, Safety Strategy and Core Benefit-Risk Documents. /li /ul h3Responsibilities /h3 ul liSupport the Coordinator in the global planning of both molecules under development and those with a Marketing Authorisation. /li liWrite, consolidate, update and distribute aggregates for global products with the cross-functional team. /li liSubmit aggregate reports to Health Authorities where applicable. /li liMonitor compliance for PSURs/PBRERs and DSURs submitted for global products/molecules under development. /li liAct as QC responsible for aggregate reports and global planning. /li liLead the process/project for cross-functional working teams. /li liManage related Health Authorities’ assessments (e.g., requests for supplementary information – RSI). /li liSupport Safety Physicians in writing relevant sections of documents for company product renewals in Addendum to the clinical overviews (ACOs) and provide the necessary support in case of RSI during the renewal procedure. /li liServe as QC responsible for the Coordinator in calculating quality Aggregate KPIs. /li liAssist TA Physicians in aligning risk management materials with current approved documents including PBRER, ACO, PADER, RMP, presentations, and signal evaluations. /li liProduce high‑quality, accurate, fit‑for‑purpose documents with clear conclusions. /li liCommunicate technical, medical and scientific information in critical submissions and internal PV documents to deliver high‑quality reports within specified timelines. /li liCollaborate cross‑functionally to continuously improve standards and best practices for medical writing. /li liUpload pharmacovigilance documents for global products in the EDMS through appropriate workflows. /li liMonitor aggregates inbox and Health Authority websites including CTIS for aggregate management purposes and share results with relevant stakeholders. /li liRepresent the MSW part in audits and inspections. /li liSupport QPO in compliance calculations related to PSURs/PBRERs and DSURs submissions and update the Regulatory Information Management System with submissions in scope. /li liSupport QPO for SOPs and other controlled documents including Working Instructions and related training. /li liSupport QPO for service agreement preparation concerning aggregates. /li /ul h3Requirements /h3 ul liMinimum 1 year of experience in pharmacovigilance (medical writing experience preferred) with practical knowledge of drafting PSUR/PBRER, PADER, ACO, RMP and DSURs. /li liMaster’s degree in science, PhD or similar. /li liCapacity to work on situations or data requiring an in-depth evaluation of various factors: /li /ul ul liData analysis. /li liPrevious medical writing experience. /li liProcedures writing and training performance. /li liKnowledge of domestic and international regulatory safety reporting requirements. /li /ul h3Benefits /h3 pNo matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. /p pWe provide top‑class benefits, including comprehensive healthcare programs, work‑life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive. /p h3Equal Opportunity Employment /h3 pChiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination. /p /p #J-18808-Ljbffr