Global Senior Patient Safety Scientist - Rare Diseases

Ipsen; Paris; Híbrido; GBP 90.000 - 130.000; Jornada completa

Descripción de la vacante

Ipsen is seeking a Global Patient Safety Senior Scientist Rare Diseases in a hybrid Paris/London role. You will lead safety assessments, support regulatory submissions, and collaborate across Clinical Development and QA to ensure robust pharmacovigilance for Rare Diseases products.

You will provide scientific safety input, manage safety data, and contribute to DSURs and SUSAR documentation while working with global teams to uphold high standards of patient safety and regulatory compliance.

Formación

• Extensive pharmacovigilance experience in the pharmaceutical industry.
• Working knowledge of global pharmacovigilance legislations.
• Experience with NDA/BLA or equivalent regulatory submissions, or regulatory agency review experience.
• Industry experience in clinical development.
• Knowledge of product development processes.
• Fluent in English.

Responsabilidades

• Provide scientific review and interpretation of safety data for aggregate reports.
• Conduct signal detection, evaluation and risk assessment; manage Risk Management Plans.
• Collaborate with Safety teams to support safety data handling and regulatory requirements.
• Review clinical trial documentation for safety data and adherence to quality standards.
• Deliver timely safety data reports to internal stakeholders and ethics committees.

Conocimientos

Pharmacovigilance experience

Pharmacovigilance regulations

NDA/BLA regulatory submissions

Clinical development

Product development knowledge

Fluent English

Educación

Bioscience degree or higher (BSc/BA/PharmD, Master, PhD)

Descripción del empleo

Ipsen is seeking a Global Patient Safety Senior Scientist Rare Diseases in a hybrid Paris/London role. You will lead safety assessments, support regulatory submissions, and collaborate across Clinical Development and QA to ensure robust pharmacovigilance for Rare Diseases products.

You will provide scientific safety input, manage safety data, and contribute to DSURs and SUSAR documentation while working with global teams to uphold high standards of patient safety and regulatory compliance.