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. Discover more here.
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
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)
- To support the Coordinator in the global planning (for both molecules under development and those with a Marketing Authorisation);
- To be responsible for writing, consolidating, updating and distributing aggregates for global products with the cross-functional team;
- To be responsible for aggregates report submission to Health Authorities where applicable;
- To be responsible for compliance monitoring both for PSURs/PBRERs and DSURs submitted for global products/ molecules under development;
- To be QC Responsible for aggregate reports and global planning;
- To lead the process/project for cross-functional working teams;
- To manage related Health Authorities’ assessments (i.e., “requests for supplementary information -RSI);
- To support the Safety Physicians in writing the relevant sections of the documents for the Company products’ renewals in Addendum to the clinical overviews (ACOs) for global products and provide the necessary support in case of RSI during the renewal procedure;
- To support/act as QC responsible the Coordinator in the calculation of quality Aggregate KPIs;
Risk Management Materials
- To support TA Physicians in aligning risk management materials with the current approved documents including PBRER, ACO, PADER, RMP, presentations, and signal evaluations;
General
- To produce high-quality, accurate and fit-for-purpose documents with clear conclusions;
- To effectively and clearly communicate technical, medical, and scientific information in critical submission and internal PV documents to deliver high-quality reports within the specified timelines;
- To collaborate cross-functionally for continuous improvement of standards and best practices for medical writing;
- To upload pharmacovigilance documents for global products in the EDMS through the appropriate workflows;
- To monitor aggregates inbox and HA websites including CTIS for aggregate management purposes (e.g. EURD list, ASR RFI) and share the results with relevant stakeholders;
- To be the representative for MSW part in audits and inspections;
- To support QPO in compliance calculations related to PSURs/PBRERs and DSURs submission and to update the Regulatory Information Management System with PSURs/PBRERs submission in scope;
- To support QPO for SOPs and other controlled documents including Working Instruction and related training;
- To support QPO for service agreement preparation concerning aggregates.
- Minimum 1 year of experience in pharmacovigilance (medical writing experience is preferred), with practical knowledge of drafting PSUR/PBRER, PADER, ACO, RMP and DSURs.
- Master’s degree in science, PhD or similar
- English fluent
- 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
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.
