Individual Case Safety Reports (ICSR) Manager, Global Patient Safety

Individual Case Safety Reports (ICSR) Manager – Global Patient Safety, Ipsen Pharma (SAS)

Ipsen is a mid‑sized global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience, with global hubs in the United States, France and the United Kingdom. We bring medicines to patients across more than 40 countries.

About the Role

Within the Global Patient Safety (GPS) department, the ICSR Manager is a key contributor in managing Individual Case Safety Reports (ICSRs). The role involves:

• Managing all ICSR topics in accordance with regulatory guidelines and Ipsen standards to ensure readiness for quality and distribution within regulatory and internal timelines.
• Collaborating closely with the external vendor responsible for ICSR management in the Ipsen Global Safety Database.

Main Responsibilities

• Oversee all GPS quality controls on data entry of cases performed by the ICSR vendor.
• Monitor the case quality indicators as defined in Ipsen standards and deliver the results.
• Perform weekly quality control of approved cases handled by the ICSR vendor.
• Work in close collaboration with the GPS Therapeutic Area team to establish a robust TA case corrections process and ensure good communication with the ICSR vendor.
• Maintain up‑to‑date and accurate data‑handling conventions for the ICSR vendor.
• Participate in operational meetings with the ICSR vendor to maintain the quality and compliance at the level expected by Ipsen.
• Ensure regular training of the ICSR vendor to maintain the required level of data‑quality governance.
• Participate as a subject‑matter expert in projects related to ICSR activities.
• Participate in the writing and updating of the documents and procedures related to the activities.
• Participate in the training of the GPS ICSR vendor on ICSR case‑management processes.
• Act for process improvement in close collaboration with all Ipsen stakeholders and external providers.

Qualifications

• Master’s Degree in Natural Sciences.
• Strong experience within Drug Safety, Clinical Development and/or Pharmacovigilance.
• MUST HAVE strong experience in Quality Assurance and case management.
• Full breadth of knowledge of all phases of drug development.
• Advanced knowledge and understanding of Pharmacovigilance.
• Strong experience of delivering ICSR reports.
• Expertise in safety data collection systems, safety reporting tools and safety databases.
• Experience collaborating with external vendors.
• Experience with compliance to internal SOPs and other requirements.
• Training on computer and software used in Pharmacovigilance and literature screening.
• Knowledge of safety evaluation, MedDRA, PV regulations.
• Proficient user of modern IT and Office software.
• Fluent in English.

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