Director / Senior Director, Project Management

Senior Director, Global Patient Safety Science
Department: Global Regulatory Affairs & Patient Safety
Business Area: R&D, Pharmacovigilance & Regulatory Affairs
Contract Type: Permanent
Everywhere in Europe, IT
Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 90 years’ experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: We are proud to have been awarded with B Corp Certification, a recognition of high social and environmental standards. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.
In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
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).
The Senior Director, Global Patient Safety Science leads the patient safety strategy and operations across Chiesi’s global portfolio, ensuring continuous monitoring of product safety, proactive risk management, and regulatory compliance. This role involves cross-functional collaboration, leadership of a dedicated safety team, and direct engagement with internal and external stakeholders, including health authorities and commercial partners. The position plays a critical role in clinical development, due diligence, and post-marketing safety activities.
He/She reports to the Vice President, Global Regulatory Affairs and Patient Safety.
Lead the Patient Safety Science team of product assigned patient safety physicians, supporting them for safety surveillance and risk management activities of their assigned Chiesi products.
Ensure up-to-date oversight of the emerging safety profile for all Chiesi products and the corresponding safety and risk management strategies.
Provide strategic medical and scientific leadership for patient safety across Chiesi’s product portfolio.
Oversee patient safety assessments during due diligence, clinical development, and post-marketing phases.
Ensure the delivery of Patient Safety Science activities including support of clinical trials, delivery of aggregate reports, signal detection, signal assessment and safety signal management, safety risk mitigation activities and the appropriate communication of safety messaging across internal and external stakeholders.
Guide the preparation and maintenance of regulatory safety documents (e.g., Represent Patient Safety in internal and external meetings, including interactions with Health Authorities.
Collaborate cross-functionally with Clinical Development, Medical Affairs, Regulatory Affairs, and external partners.
Active member of the GRAPS Leadership Team and contribute to the Regulatory Affairs and Patient Safety vision
At least 10 years of experience in global medical safety / pharmacovigilance roles in a global pharmaceutical/biotech company, working with development programs, regulatory submissions and post-marketing safety surveillance
Proven team leadership and line management experience and skills within a patient safety or similar setting.
Diverse experience across pharmacovigilance, including systems, operations and safety science at global and local levels, for different types of products (small molecules, biologics, combination products)
Medical degree (MD)
Languages
Excellent command of English (spoken and written).
Strong ethical sense combined with quality and patient safety mindset
We firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being. We offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
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