Global Patient Safety Senior Scientist — Rare Diseases

Ipsen Pharma (SAS); Paris; Sur place; EUR 110 000 - 150 000; Plein temps

Résumé du poste

Ipsen is seeking a Global Patient Safety Senior Safety to lead pharmacovigilance activities across development and marketed products. You will provide expert safety data interpretation, oversee signal detection, and drive risk management actions in collaboration with GPS teams.

You will ensure regulatory-aligned safety reporting, contribute to benefit-risk evaluations, and support clinical development with timely safety input and DSUR/SUSAR documentation.

Qualifications

• Bioscience graduate or higher degree (Master/PhD).
• Extensive pharmacovigilance experience in pharma.
• Knowledge of worldwide pharmacovigilance legislation.
• Experience with NDA/BLA or regulatory submissions.
• Industry experience in clinical development and product development processes.
• Fluent in English.

Responsabilités

• Provide scientific review and interpretation of safety data for aggregate reports.
• Conduct signal detection, evaluation and risk assessment for safety data.
• Collaborate cross-functionally to meet regulatory objectives and timelines.
• Deliver timely safety data reviews and reports to internal stakeholders.
• Prepare responses to safety questions and manage external vendors.
• Ensure SAE reporting and pharmacovigilance procedures are up to date.

Connaissances

Pharmacovigilance

Regulatory submissions

Cross-functional collaboration

Scientific writing

English fluency

Formation

Bachelor/Master in bioscience

PhD

Description du poste

Ipsen is seeking a Global Patient Safety Senior Safety to lead pharmacovigilance activities across development and marketed products. You will provide expert safety data interpretation, oversee signal detection, and drive risk management actions in collaboration with GPS teams.

You will ensure regulatory-aligned safety reporting, contribute to benefit-risk evaluations, and support clinical development with timely safety input and DSUR/SUSAR documentation.