Global Pharmacovigilance Medical Safety Writer - Temporary

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/PBRERs and DSURs submissions and update the Regulatory Information Management System accordingly.

Support QPO for SOPs and other controlled documents, including Working Instructions and related training.

Assist QPO with service‑agreement preparation concerning aggregates.

You will need to have

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 equivalent.

Capacity to work on situations or data requiring in‑depth evaluation of various factors, including:

Data analysis.

Previous medical writing experience.

Procedures writing and training performance.

Knowledge of domestic and international regulatory safety reporting requirements.

Location Italy with possibility of smart working.

What we offer 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.

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.

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