Senior Global Patient Safety Physician

Location: Spoleto

Senior Global Patient Safety Physician Chiesi Poreta, Umbria, 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.

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.

This is what you will do

The Senior Global Patient Safety Physician provides safety-scientific and medical expertise to the conduct of safety science activities and safety-related clinical development contributions for assigned development and marketed product(s).

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

The Senior Global Patient Safety Physician can be appointed as the safety science lead (as per the Safety Lead Role Card) to responsibly 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.

You will be responsible for provides safety-scientific and medical expertise to develop a Safety Science strategy and conduct safety surveillance and risk management activities for assigned development and marketed product(s).

Works in a fully integrated into a cross-functional context and deliver to the highest scientific and compliance standards.

Contributes to a forward-looking safety surveillance and risk management strategy for the assigned product(s) aligned with regulatory expectations and corporate priorities.

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 BRT.

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.

Develops 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 remediation activities as required.

Participates in scientific development opportunities to strengthen expertise in safety assessment and methodology.

Participates in innovation and best practices in safety science to strengthen Chiesi's development and lifecycle management capabilities for the assigned products.

Supports the engagement with external stakeholders, academic groups, and service providers to enhance scientific credibility and innovation.

Contributes to the integration of emerging science, regulatory trends, and best practices into Safety Science for the concerned product(s).

Qualifications

Medical degree, preferably with experience in clinical practice.

Minimum 5 years of experience as a safety physician in safety science within a pharmaceutical or CRO…