Senior Global Patient Safety Physician

Job description

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. 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 for 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 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 Particiates 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) You will need to have 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 Location Europe (flexible) – remote or hybrid Compensation range The minimum salary for this role is €68.500, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations. This role is eligible to participate in an annual bonus scheme, subject to company and individual performance. In addition, we offer a comprehensive benefits package including company car, pension, private medical insurance, wellbeing programme, flexible benefits programme and more. The package outlined above is based on the role being located in Italy. Where the role is offered in a different country, the applicable salary, bonus and benefits will be aligned to the relevant local market and internal frameworks. Full details of the applicable package will be provided at the appropriate stage of the recruitment process. What we offer No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive. Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.