Senior Global Patient Safety Physician

ppDepartment: Global Regulatory Affairs Patient Safety /p pBusiness Area: RD, Pharmacovigilance Regulatory Affairs /p pJob Type: Direct Employee /p pContract Type: Permanent /p pLocation: Europe, remote, IT /p h3About the role /h3 pThe 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). /p pThis 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. /p pThe 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. /p h3This is what you will do /h3 ul liProvides 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) /li liWorks in a fully integrated into a cross‑functional context and deliver to the highest scientific and compliance standards. /li liContributes to a forward‑looking safety surveillance and risk management strategy for the assigned product(s) aligned with regulatory expectations and corporate priorities. /li liEnsures continuous access to all relevant safety data to support the integrated oversight of emerging safety profiles across the assigned product(s) /li liContributes to the evaluation of safety issues using all relevant data sources /li liCollaborates with stakeholders from Clinical Development, Medical Affairs, Regulatory Affairs, Quality, and other functions in the context of the BRT /li liWorks with clinical teams to implement safety input into clinical development plans, protocols, study documents, and regulatory submissions. /li liDevelops Health Hazard Assessments for quality complaints and manufacturing deviations, in line with the GMP quality process. /li liDevelops 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 /li liMakes Safety Science contributions to due diligence, partnerships, licensing opportunities, and acquisition assessments. /li liSupports the partner engagements for the continuous information exchange, as per the PV agreement /li liParticiates in the implementation of improvement initiatives to increase efficiency, quality, and scientific value within Safety Science activities. /li liCollaborates 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 /li liCollaborates with Safety Operations on a day to day basis to have awareness of the flow of cases the coding and case quality. /li liContributes to the development of safety communications material for global Health Authorities and external stakeholders. /li liParticipates as subject matter expert during inspections, audits, and regulatory interactions, participating in remediation activities as required. /li liParticipates in scientific development opportunities to strengthen expertise in safety assessment and methodology. /li liParticipates in innovation and best practices in safety science to strengthen Chiesi’s development and lifecycle management capabilities for the assigned products /li liSupports the engagement with external stakeholders, academic groups, and service providers to enhance scientific credibility and innovation. /li liContributes to the integration of emerging science, regulatory trends, and best practices into Safety Science for the concerned product(s) /li /ul h3You will need to have /h3 ul liMedical degree, preferably with experience in clinical practice. /li liMinimum 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 /li liProven leadership of global teams and complex safety portfolios across early and late development and post‑approval products /li liExpertise in global PV regulations, inspections, governance, and cross‑functional collaboration /li liExperience across multiple product modalities (small molecules, biologics, drug/device combination products) and therapeutic areas /li liStrategic mindset with the ability to translate safety science into business and development decisions. /li liStrong leadership and sound judgment, capable of managing complexity, risk, and critical issues. /li liProven ability to influence senior stakeholders and collaborate effectively across matrix and cross‑functional environments. /li liExcellent communication, analytical, and organizational skills, combined with high ethical standards and a strong commitment to patient safety and quality /li /ul h3Location /h3 pEurope (flexible) – remote or hybrid /p h3Compensation range /h3 pThe 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. /p pThis role is eligible to participate in an annual bonus scheme, subject to company and individual performance. /p pIn addition, we offer a comprehensive benefits package including company car, pension, private medical insurance, wellbeing programme, flexible benefits programme and more. /p pWhere 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. /p h3Benefits /h3 pWe provide top‑class benefits, including comprehensive healthcare programmes, 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. /p h3Equal Opportunity Employer /h3 pChiesi 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. /p /p #J-18808-Ljbffr