Patient Safety Science Lead

Chiesi Group; Brussel; Hybrid; EUR 69,000 - 86,000; Full time

Benefits offered by this job

Company car

Pension

Private medical insurance

Wellbeing programme

Flexible benefits

Relocation support

Job summary

Chiesi Group is seeking a Patient Safety Science Lead to provide scientific leadership across safety activities for development and marketed products. You will manage safety surveillance, risk assessments, and governance in a cross-functional, global context.

The role requires an advanced life science degree (PhD preferred), 8+ years in patient safety and 6+ years in safety science, and a proven ability to lead complex safety portfolios.

Qualifications

• Advanced degree in life science, pharmacy, medicine or related field; PhD preferred.
• Minimum 8 years in patient safety with 6+ years in safety science within pharmaceutical or CRO.
• Proven leadership of global teams and complex safety portfolios across development and post-approval.
• Expertise in global PV regulations, inspections, governance, and cross-functional collaboration.
• Experience across multiple product modalities and therapeutic areas.
• Strategic and enterprise mindset with the ability to translate safety science into decision-ready insights.
• Strong, balanced judgment with the ability to lead through complexity and risk.

Responsibilities

• Provides safety-scientific leadership to safety science activities for assigned products.
• Works with cross-functional teams to ensure high scientific and compliance standards.
• Ensures access to safety data to support oversight of safety profiles across products.
• Assesses safety issues using all relevant data sources.
• Collaborates with Clinical Development, Medical Affairs, Regulatory, and Quality.
• Integrates safety input into development plans and regulatory submissions.
• Develops health hazard assessments for quality and manufacturing issues.
• Participates in due diligence and partnerships for safety science opportunities.
• Supports external stakeholders and academic groups to enhance scientific credibility.
• Contributes to safety science innovation and best practices.

Skills

Safety science leadership

Global team leadership

PV regulations

Cross-functional collaboration

Strategic thinking

Safety data interpretation

Education

Advanced degree in life science/pharmacy/medicine

PhD preferred

Job description

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).

You will need to have

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

You will need to have

Location

Europe (flexible) – remote or hybrid

Compensation range

The budgeted salary range approved for this role is between €68.500 and €85.600. This range reflects the typical compensation expected for candidates with the experience and expertise required for the position.

Final offer may vary based on the selected candidate's skills, experience, qualifications, overall profile, 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.