Patient Safety Science Lead

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ppSelect how often (in days) to receive an alert: /p pDepartment: Global Regulatory Affairs Patient Safety /p pBusiness Area: RD, Pharmacovigilance Regulatory Affairs /p pJob Type: Direct Employee /p pContract Type: Permanent /p pLocation: Parma, IT /p pbAbout us /b /p pChiesi 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.
/p pAt 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.
/p pDiversity 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.
/p pbChiesi Research Development /b /p pOur RD 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, RD 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).
/p pbWho we are looking for /b /p h3bThis is what you will do /b /h3 pThe Patient Safety Science Lead provides safety-scientific 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 scientific leadership to ensure that the safety profiles of the concerned products are proactively monitored and assessed, using all available data sources.
/p pThe Patient Safety Science Lead is responsible to 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, soliciting medical expertise where required.
/p h3bYou will be responsible for /b /h3 ul liProvides safety-scientific expertise to develop a Safety Science strategy and conducts safety surveillance and risk management activities for assigned development and marketed product(s), aligned with regulatory expectations and corporate priorities.
/li liWorks in a fully integrated cross-functional context and delivers to the highest scientific and compliance standards.
/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 Benefit Risk Team /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 liParticipate 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 liParticipates 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 h3bYou will need to have /b /h3 ul liAdvanced degree In Life Science, Pharmacy, Medicine or a related scientific discipline.
A PhD in a topic relevant to the position is preferred.
/li liMinimum of 8 years of general experience in patient safety and a minimum of 6 years of experience 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 and enterprise mindset with the ability to translate safety science into decision-ready strategic insights /li liStrong, balanced judgment with the confidence to lead through complexity and risk /li liProven ability to influence senior stakeholders and operate effectively in matrix environments /li liCrisis leadership capability, including issue escalation and resolution /li liConfident leader of a diverse team, with the ability to mentor and develop talent /li liExceptional communication, relationship-building, and collaboration skills, with the ability to integrate different viewpoints in the final decision /li liCompetence in working across organizational and company boundaries /li liSuperb planning, organizational and analytical skills, with a detail- and result-oriented approach /li liHigh ethical standards and an unwavering commitment to patient safety and quality /li /ul h3bLocation /b /h3 pEurope (flexible) – remote or hybrid /p h3bCompensation range /b /h3 pTheminimumsalary for this role is€******,aligned to our established salary framework.
The final offer will reflect the candidate's skills, experience,qualificationsand internal equity considerations.
/p pThis role is eligible toparticipatein an annual premio scheme, subject to company and individual performance.
/p pIn addition, we offer a comprehensive benefits package includingcompany car,pension, private medical insurance, wellbeing programme, flexible benefits programme and more.
/p pThe 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.
/p pbWhat we offer /b /p pNo 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.
/p pWe 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.
/p 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.
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7jozeh