Global Lead, Patient Safety Science

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

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.