Patient Safety Science Lead

Chiesi Farmaceutici S.p.A.; Parma; Ibrido; EUR 62.000 - 75.000; Tempo pieno

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. in Parma, Italy, is seeking a Patient Safety Science Lead to provide safety-scientific leadership for assigned development and marketed products.

You will monitor safety profiles and drive predictive safety strategies across global programs in a cross-functional, compliant way. The role requires leadership of safety surveillance, collaboration with Clinical Development, Regulatory Affairs, and Quality, and participation in inspections and regulatory interactions.

Competenze

• Advanced degree in Life Science, Pharmacy or Medicine with PhD preferred.
• 8+ years in patient safety and 6+ years in safety science within pharma or CRO.
• Global teams leadership across development and post-approval products.
• Expertise in global PV regulations, inspections, and governance.
• Experience across multiple product modalities and therapeutic areas.
• Strategic, enterprise-minded with strong communication skills.

Mansioni

• Provides safety-scientific expertise to develop Safety Science strategy.
• Leads safety surveillance and risk management for products.
• Collaborates with Clinical Development, Medical Affairs, Regulatory, and Quality.
• Develops Health Hazard Assessments for quality and manufacturing deviations.
• Supports safety input into regulatory submissions and due diligence.
• Participates in inspections, audits and regulatory interactions.

Conoscenze

Safety leadership

Regulatory expertise

Cross-functional collaboration

Strategic thinking

Crisis leadership

Influence senior stakeholders

Communication skills

Formazione

Advanced degree in Life Science/Pharmacy/Medicine

PhD preferred

Descrizione del lavoro

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Department: Global Regulatory Affairs & Patient Safety

Business Area: R&D, Pharmacovigilance & Regulatory Affairs

Job Type: Direct Employee

Contract Type: Permanent

Location: Parma, IT

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 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 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.

You will be responsible for

• Provides 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.
• Works in a fully integrated cross-functional context and delivers to the highest scientific and compliance standards.
• 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 Benefit Risk Team
• 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.
• Participate 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
• Participates 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

• 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

Theminimumsalary for this role is€68.500,aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience,qualificationsand internal equity considerations.

This role is eligible toparticipatein an annual bonus scheme, subject to company and individual performance.

In addition, we offer a comprehensive benefits package includingcompany 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.

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