CG
Senior Global Patient Safety Physician (Europe, remote, IT)
Contract type
Ongoing
Work mode
Remote · Europe
Experience
Senior · 5+ years
Job description
The Senior Global Patient Safety Physician provides safety-scientific and medical expertise for safety surveillance and risk management activities for assigned development and marketed products. The role can be appointed as safety science lead for assigned products.
At a glance
- Work mode
- Remote · Europe
What you'll do
- 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 fully integrated into a cross-functional context and delivers 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
- Contributes 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 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)
What we're looking for
- 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 organization, with experience in post-marketing and clinical development safety
- Proven leadership of global teams and complex safety portfolios across early and late development and post-approval products
- Expertise in global PV regulations, inspections, governance, and cross-functional collaboration
- Experience across multiple product modalities (small molecules, biologics, drug/device combination products) and therapeutic areas
- Strategic mindset with the ability to translate safety science into business and development decisions
- Strong leadership and sound judgment, capable of managing complexity, risk, and critical issues
- Proven ability to influence senior stakeholders and collaborate effectively across matrix and cross-functional environments
- Excellent communication, analytical, and organizational skills, combined with high ethical standards and a strong commitment to patient safety and quality
Your team
Chiesi Research & Development
Safety Science activities within Chiesi Research & Development
Benefits
Comprehensive benefits package including company car, pension, private medical insurance, wellbeing programme, flexible benefits programme and more
Competitive salary package comprising a basic salary, performance bonuses, and benefits benchmarked against the external market
- Annual bonus scheme, subject to company and individual performance
- Comprehensive healthcare programs
- Work-life balance initiatives
- Robust relocation support
- Flexible working arrangements
- Remote work options
- Tax assistance services for foreign colleagues
Apply
About Chiesi Group
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 research, develop, and market innovative drugs across main therapeutic areas. As a Benefit Corporation and a certified B Corp, sustainability is embedded in the bylaws and impact is continuously measured.
Mission
Promoting a healthier world for our people, patients, and the planet
Key facts
- More than 8,000 employees
- Parma, Italy
- biopharmaceutical
- 90 years' experience
- Operating in more than 30 countries
- More than 8,000 employees across the group
- Benefit Corporation and certified B Corp
What they value
- Reliability
- Transparency
- Ethical behaviour
- Sustainability
- Diversity and inclusion