Global Pharmacovigilance Medical Safety Writer - Temporary

Global Pharmacovigilance Medical Safety Writer - Temporary

Date: 28 Apr 2026

Department: Global Regulatory Affairs & Patient Safety

Business Area: R&D, Pharmacovigilance & Regulatory Affairs

Job Type: Direct Employee

Contract Type: Temporary

Location: Italy (Parma) with possibility of smart working

What you will do

• Process 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.

Responsibilities

• Support the Coordinator in the global planning of 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.
• Act as QC responsible for aggregate reports and global planning.
• Lead the process/project for cross-functional working teams.
• Manage related Health Authorities’ assessments (e.g., requests for supplementary information – RSI).
• Support 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.
• Serve as QC responsible for the Coordinator in calculating quality Aggregate KPIs.
• Assist TA Physicians in aligning risk management materials with current approved documents including PBRER, ACO, PADER, RMP, presentations, and signal evaluations.
• Produce high‑quality, accurate, fit‑for‑purpose documents with clear conclusions.
• Communicate technical, medical and scientific information in critical submissions and internal PV documents to deliver high‑quality reports within specified timelines.
• Collaborate cross‑functionally to continuously improve standards and best practices for medical writing.
• Upload pharmacovigilance documents for global products in the EDMS through appropriate workflows.
• Monitor aggregates inbox and Health Authority websites including CTIS for aggregate management purposes and share results with relevant stakeholders.
• Represent the MSW part in audits and inspections.
• Support QPO in compliance calculations related to PSURs/PBRERs and DSURs submissions and update the Regulatory Information Management System with submissions in scope.
• Support QPO for SOPs and other controlled documents including Working Instructions and related training.
• Support QPO for service agreement preparation concerning aggregates.

Requirements

• Minimum 1 year of experience in pharmacovigilance (medical writing experience preferred) with practical knowledge of drafting PSUR/PBRER, PADER, ACO, RMP and DSURs.
• Master’s degree in science, PhD or similar.
• Capacity to work on situations or data requiring an in-depth evaluation of various factors:

• Data analysis.
• Previous medical writing experience.
• Procedures writing and training performance.
• Knowledge of domestic and international regulatory safety reporting requirements.

Benefits

No 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.

We 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.

Equal Opportunity Employment

Chiesi 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.