Senior Global Patient Safety Physician

Chiesi; Ancona; In loco; EUR 150.000 - 210.000; Tempo pieno

Vantaggi offerti da questo lavoro

Company car

Pension

Private medical insurance

Relocation support

Descrizione del lavoro

Chiesi is seeking a Senior Global Patient Safety Physician to lead safety science for assigned products, shaping proactive risk management and safety surveillance across development and lifecycle management.

You will collaborate with Clinical Development, Medical Affairs, Regulatory, Quality, and external partners to integrate safety data into development plans and submissions, driving science-led decisions for compliant, data-driven safety evaluations.

Competenze

• Medical degree with clinical practice experience.
• Minimum 5 years as a safety physician in pharmaceutical or CRO setting.
• Experience leading global safety teams and portfolios across development stages and post-approval.
• Expertise in global PV regulations, governance, and inspections.
• Experience with multiple product modalities and therapeutic areas.

Mansioni

• Develop and implement a Safety Science strategy and oversee safety surveillance for development and marketed products.
• Lead cross-functional collaboration to meet scientific and regulatory standards.
• Ensure access to comprehensive safety data for integrated product safety oversight.
• Evaluate safety issues using diverse data sources and methods.
• Incorporate safety input into clinical development plans, protocols, and regulatory submissions.
• Develop Health Hazard Assessments for quality issues and GMP deviations.
• Create and maintain safety surveillance and risk management documents and plans.
• Contribute to due diligence, partnerships, licensing, and acquisition assessments.
• Support external stakeholder engagement and communication with Health Authorities.
• Attend inspections, audits, and regulatory interactions as SME and participate in remediation.
• Advance safety science through innovation, best practices, and professional development.
• Collaborate with external providers to manage outsourced safety activities and data flow.
• Contribute to safety communications and information exchange with providers and partners.
• Assist in improving efficiency, quality, and scientific value within Safety Science.

Conoscenze

Leadership

Communication

Safety science

Pharmacovigilance

Regulatory knowledge

Strategic thinking

Stakeholder management

Data-driven decisions

Risk management

Formazione

Medical degree

Descrizione del lavoro

As Senior Global Patient Safety Physician at Chiesi, you lead safety science for assigned products, shaping proactive risk management and safety surveillance. You collaborate across Clinical Development, Medical Affairs, Regulatory, Quality and external partners to integrate safety data into development plans and submissions. You drive science-led decisions, ensuring compliant, data-driven safety evaluations throughout development and lifecycle management. This role offers impact in a global, cross-functional setting with a strong focus on patient safety and innovation.

• company car
• pension
• private medical insurance
• relocation support
• Develop and implement a Safety Science strategy and oversee safety surveillance for development and marketed products
• Lead cross-functional collaboration to meet scientific and regulatory standards
• Ensure access to comprehensive safety data for integrated product safety oversight
• Evaluate safety issues using diverse data sources and methods
• Incorporate safety input into clinical development plans, protocols, and regulatory submissions
• Develop Health Hazard Assessments for quality issues and GMP deviations
• Create and maintain safety surveillance and risk management documents and plans
• Contribute to due diligence, partnerships, licensing, and acquisition assessments
• Support external stakeholder engagement and communication with Health Authorities
• Attend inspections, audits, and regulatory interactions as SME and participate in remediation
• Advance safety science through innovation, best practices, and professional development
• Collaborate with external providers to manage outsourced safety activities and data flow
• Contribute to safety communications and information exchange with providers and partners
• Assist in improving efficiency, quality, and scientific value within Safety Science
• Medical degree with clinical practice experience
• Minimum 5 years as a safety physician in pharmaceutical or CRO setting
• Experience leading global safety teams and portfolios across development stages and post-approval
• Expertise in global PV regulations, governance, and inspections
• Experience with multiple product modalities and therapeutic areas
• Strategic mindset translating safety science into business decisions
• Strong leadership, judgment, and ability to manage complexity and risk
• Proven ability to influence senior stakeholders in matrix environments
• Excellent communication, analytical, and organizational skills
• High ethical standards focused on patient safety and quality
• leadership
• communication
• Safety science strategy
• Pharmacovigilance regulations and inspections

Senior Global Patient Safety Physician ancona, marche, it