Global Pharmacovigilance Medical Safety Writer - Temporary

Questa posizione è in Chiesi Group Riassunto dell'opportunità da parte della

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Chiesi Group

ricerca un

Global Pharmacovigilance Medical Safety Writer

con almeno

1 anno di esperienza in farmacovigilanza

e laurea magistrale in scienze o titolo equivalente. Il candidato si occuperà della redazione e gestione di documenti di farmacovigilanza complessi a supporto di prodotti globali, collaborando con team multidisciplinari. L'offerta include possibilità di smart working, benefit completi e ambiente di lavoro internazionale.

Il processo di selezione sarà interamente gestito da Chiesi Group. -- # 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:

Parma, IT About us Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better. Chiesi Research & Development Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China). Who we are looking for This is 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 but not limited to Periodic Safety Reports, Safety Strategy and Core Benefit-Risk Documents. You will be responsible for Aggregates (PBRERs/PSURs, PADERs, RMPs, DSURs, ACOs):

Support the Coordinator in global planning for both molecules under development and those with 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 and 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 including requests for supplementary information (RSI); Support Safety Physicians in writing relevant document sections for product renewals and during RSI; Support/act as QC responsible the Coordinator in calculating quality Aggregate KPIs;

Risk Management Materials:

Support TA Physicians in aligning risk management materials with current approved documents such as PBRER, ACO, PADER, RMP, presentations, and signal evaluations;

General:

Produce high-quality, accurate, and fit-for-purpose documents with clear conclusions; Communicate technical, medical, and scientific information effectively in critical submission and internal PV documents within specified timelines; Collaborate cross-functionally for continuous improvement of medical writing standards and best practices; Upload pharmacovigilance documents for global products in the EDMS via appropriate workflows; Monitor aggregates inbox and Health Authority websites including CTIS for aggregate management and share results with stakeholders; Be the MSW representative in audits and inspections; Support QPO in compliance calculations related to PSURs/PBRERs and DSURs submissions and update Regulatory Information Management System accordingly; Support QPO for SOPs, 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 similar; Fluent English; Capacity to work with complex data and situations requiring in-depth evaluation of: Data analysis; Previous medical writing experience; Procedure writing and training; Knowledge of domestic and international regulatory safety reporting requirements.

Location Italy with possibility of smart working What we offer 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. 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. DISCOVER ALL OUR JOB OPPORTUNITIES -- [#J-ENTERPRISE]