Patient Safety Science Lead

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.

Non si lasci sfuggire questa opportunità: si candidi rapidamente se la sua esperienza e le sue competenze corrispondono a quanto descritto di seguito.

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 forThis is what you will do

The Patient Safety Science Lead provides safety-scientific expertise to the conduct of safety science activities and safety‑related clinical development contributions for assigned development and marketed product(s).

This role requires scientific leadership to ensure that the safety profiles of the concerned products are proactively monitored and assessed, using all available data sources.

The Patient Safety Science Lead is responsible to manage safety surveillance and risk management activities for assigned product(s) and ensure proactive, science‑driven safety evaluation based on predictive safety strategies, robust surveillance, and informed benefit–risk decisions, soliciting medical expertise where required.

You will be responsible for

• Provides safety-scientific expertise to develop a Safety Science strategy and conducts safety surveillance and risk management activities for assigned development and marketed product(s), aligned with regulatory expectations and corporate priorities.
• Works in a fully integrated cross‑functional context and delivers to the highest scientific and compliance standards.
• Ensures continuous access to all relevant safety data to support the integrated oversight of emerging safety profiles across the assigned product(s)
• Contributes to the evaluation of safety issues using all relevant data sources
• Collaborates with stakeholders from Clinical Development, Medical Affairs, Regulatory Affairs, Quality, and other functions in the context of the Benefit Risk Team
• Works with clinical teams to implement safety input into clinical development plans, protocols, study documents, and regulatory submissions.
• Develops Health Hazard Assessments for quality complaints and manufacturing deviations, in line with the GMP quality process.
• Participate to the development of safety surveillance and risk management plans and other outputs for assigned product(s) as per relevant procedures, maintains the respective documentation and logs
• Makes Safety Science contributions to due diligence, partnerships, licensing opportunities, and acquisition assessments.
• Supports the partner engagements for the continuous information exchange, as per the PV agreement
• Participates in the implementation of improvement initiatives to increase efficiency, quality, and scientific value within Safety Science activities.
• Collaborates with external providers managing outsourced activities for Patient Safety Science to ensure the communication flow for required data and the receipt and documentation of deliverables
• Collaborates with Safety Operations on a day‑to‑day basis to have awareness of the flow of cases, the coding, and case quality.
• Contributes to the development of safety communications material for global Health Authorities and external stakeholders.
• Participates as subject matter expert during inspections, audits, and regulatory interactions, participating in reme