[Hiring] Senior Global Patient Safety Physician @Chiesi Group

Role Description

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:

• Providing 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).
• Working in a fully integrated cross-functional context and delivering to the highest scientific and compliance standards.
• Contributing to a forward-looking safety surveillance and risk management strategy for the assigned product(s) aligned with regulatory expectations and corporate priorities.
• Ensuring continuous access to all relevant safety data to support the integrated oversight of emerging safety profiles across the assigned product(s).
• Contributing to the evaluation of safety issues using all relevant data sources.
• Collaborating with stakeholders from Clinical Development, Medical Affairs, Regulatory Affairs, Quality, and other functions in the context of the BRT.
• Working with clinical teams to implement safety input into clinical development plans, protocols, study documents, and regulatory submissions.
• Developing Health Hazard Assessments for quality complaints and manufacturing deviations, in line with the GMP quality process.
• Developing safety surveillance and risk management plans and other outputs for assigned product(s) as per relevant procedures, maintaining the respective documentation and logs.
• Making Safety Science contributions to due diligence, partnerships, licensing opportunities, and acquisition assessments.
• Supporting partner engagements for continuous information exchange, as per the PV agreement.
• Participating in the implementation of improvement initiatives to increase efficiency, quality, and scientific value within Safety Science activities.
• Collaborating 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.
• Collaborating with Safety Operations on a day-to-day basis to have awareness of the flow of cases, the coding, and case quality.
• Contributing to the development of safety communications material for global Health Authorities and external stakeholders.
• Participating as subject matter expert during inspections, audits, and regulatory interactions, participating in remediation activities as required.
• Participating in scientific development opportunities to strengthen expertise in safety assessment and methodology.
• Participating in innovation and best practices in safety science to strengthen Chiesi’s development and lifecycle management capabilities for the assigned products.
• Supporting engagement with external stakeholders, academic groups, and service providers to enhance scientific credibility and innovation.
• Contributing 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 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.

Requirements

• Location: Europe (flexible) – remote or hybrid.

Benefits

• Minimum salary for this role is €68,500, aligned to our established salary framework.
• Final offer will reflect the candidate’s skills, experience, qualifications, and internal equity considerations.
• Eligible to participate in an annual bonus scheme, subject to company and individual performance.
• Comprehensive benefits package including company car, pension, private medical insurance, wellbeing programme, flexible benefits programme, and more.
• Salary, bonus, and benefits will be aligned to the relevant local market and internal frameworks if the role is offered in a different country.