[Hiring] Patient Safety Science Lead @Chiesi Group

Role Description

The 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).

This role requires scientific leadership to ensure that the safety profiles of the concerned products are proactively monitored and assessed, using all available data sources.

The Patient Safety Science Lead is responsible for managing safety surveillance and risk management activities for assigned product(s) and ensuring proactive, science-driven safety evaluation based on predictive safety strategies, robust surveillance, and informed benefit–risk decisions, soliciting medical expertise where required.

You will be responsible for:

• Providing safety-scientific expertise to develop a Safety Science strategy and conducting safety surveillance and risk management activities for assigned development and marketed product(s), aligned with regulatory expectations and corporate priorities.
• Working in a fully integrated cross-functional context and delivering to the highest scientific and compliance standards.
• 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 Benefit Risk Team.
• 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.
• Participating in the development of 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

• Advanced degree in Life Science, Pharmacy, Medicine or a related scientific discipline. A PhD in a topic relevant to the position is preferred.
• Minimum 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.
• 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 and enterprise mindset with the ability to translate safety science into decision-ready strategic insights.
• Strong, balanced judgment with the confidence to lead through complexity and risk.
• Proven ability to influence senior stakeholders and operate effectively in matrix environments.
• Crisis leadership capability, including issue escalation and resolution.
• Confident leader of a diverse team, with the ability to mentor and develop talent.
• Exceptional communication, relationship-building, and collaboration skills, with the ability to integrate different viewpoints in the final decision.
• Competence in working across organizational and company boundaries.
• Superb planning, organizational and analytical skills, with a detail- and result-oriented approach.
• High ethical standards and an unwavering 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.

• Top-class benefits, including comprehensive healthcare programs.
• Work-life balance initiatives.
• Robust relocation support.
• Competitive salary package, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market.
• Flexible working arrangements and remote work options.
• Tax assistance services for foreign colleagues.

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.