Lead Global Patient Safety Scientist — Rare Diseases

Ipsen; Paris; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Ipsen is seeking a senior pharmacovigilance professional to lead safety activities across development and marketed products. You will review safety data, conduct signal detection, and contribute to risk management plans while working with GPS and external partners.

The role requires extensive pharmacovigilance experience, knowledge of global regulations, and fluent English. You will collaborate with Clinical, Regulatory and Quality teams to ensure timely safety reporting and regulatory

Qualifications

• Fluent in English with strong written and spoken communication.
• Extensive pharmacovigilance experience in pharmaceutical industry.
• Working knowledge of pharmacovigilance legislations worldwide.
• Experience with NDA/BLA or regulatory submissions or regulatory agency review is a plus.

Responsabilités

• Provide scientific review and interpretation of safety data for safety reports.
• Conduct signal detection, signal evaluation and risk assessment for safety data across trials and products.
• Collaborate cross-functionally to meet Clinical, Franchise, Asset Team and Regulatory objectives with timely safety reports.
• Present clinical data clearly in verbal and written formats.
• Lead safety teams and coordinate with CROs/vendors for safety documentation and reporting.
• Ensure timely DSURs/SUSARs and regulatory safety reporting to investigators and committees.
• Maintain awareness of pharmacovigilance guidance and SOPs, proposing improvements.
• Collaborate with manufacturing and QSEB on safety evaluations.
• Provide input on medical devices/digital media safety where applicable.
• Lead a Safety Asset Lead role for assigned products when required.

Connaissances

Fluent in English

Formation

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

Description du poste

Ipsen is seeking a senior pharmacovigilance professional to lead safety activities across development and marketed products. You will review safety data, conduct signal detection, and contribute to risk management plans while working with GPS and external partners.

The role requires extensive pharmacovigilance experience, knowledge of global regulations, and fluent English. You will collaborate with Clinical, Regulatory and Quality teams to ensure timely safety reporting and regulatory