> Markdown version of [/jobs/ext/1566656-individual-case-safety-reports-icsr-manager-global-patient-safety](https://www.wearedevelopers.com/jobs/ext/1566656-individual-case-safety-reports-icsr-manager-global-patient-safety). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Individual Case Safety Reports (ICSR) Manager, Global Patient Safety - **Company:** Groupe Ipsen - **Location:** Paris, France - **Contract:** Permanent contract - **Skills:** Databases, Global Positioning Systems (GPS), Office Suite, Tools for Reporting - **Published:** July 8, 2026 - **Apply:** https://espace-emploi.agefiph.fr/jobs/21368795 ## About the Role * 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 ICSRs * Expertise in safety data collection systems, safety reporting tools and safety databases, * Experience collaborating with external vendors * Experience with complying to internal SOPs and other requirements * Training on computer/software used in Pharmacovigilance & literature screening * Knowledge of Safety evaluation, MedDRA, PV regulations * Proficient user of modern IT and Office software ## Description * Manage all ICSRs topics with respect of the regulatory guidelines and Ipsen standards in ensuring ICSRs readiness for quality and distribution under the regulatory and internal timelines. * Work in close collaboration with the external vendor who is responsible of ICSRs management in the Ipsen Global Safety Database. Main Responsibilities Quality control process: * Oversee all GPS quality controls on data entry of cases performed by 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 ICSR vendor * Work in close collaboration with GPS Therapeutic Area team to establish a robust TA case corrections process and ensure good communication with ICSR Vendor * Be responsible to maintain up-to-date and accurate the Data Handling conventions for the ICSR vendor GPS ICSR Vendor management: * Participate in operational meetings with the ICSR vendor to maintain the quality and compliance on the level expected by Ipsen * Ensure regular training of ICSR Vendor to maintain the level needed with the data quality governance Transversal activities: * Participate as Subject Matter Expert to the projects related to ICSRs activities * Participate in the writing and updating of the documents/procedures related to the activities * Participate in the training of GPS ICSR vendor on ICSR case management processes * Act for process improvement in close collaboration with all Ipsen stakeholders & external providers * Coordinate outsourced activities ## Related Videos - [Reporting Active Exploits in 24 Hours: Are You Ready for the CRA?](https://www.wearedevelopers.com/videos/100248-reporting-active-exploits-in-24-hours-are-you-ready-for-the-cra) - [Kubernetes and Microservices with Multi-Model Databases](https://www.wearedevelopers.com/videos/382-kubernetes-and-microservices-with-multi-model-databases) - [Minimising the Carbon Footprint of Workloads](https://www.wearedevelopers.com/videos/1198-minimising-the-carbon-footprint-of-workloads) - [One Platform Could Not Fit Them All](https://www.wearedevelopers.com/videos/1919-one-platform-could-not-fit-them-all) - [Fighting Fraud with an AI Grandma - Ben Hopkins and Morten Legarth from faith @ VCCP](https://www.wearedevelopers.com/videos/1316-fighting-fraud-with-an-ai-grandma-ben-hopkins-and-morten-legarth-from-faith-vccp) - [How Sparking Developer Joy Unlocks Developer Productivity](https://www.wearedevelopers.com/videos/613-how-sparking-developer-joy-unlocks-developer-productivity) ## Related Articles - [Best Companies to Work For in Paris: Top 25 Companies in 2023 ](https://www.wearedevelopers.com/magazine/190-best-companies-to-work-for-in-paris-top-25-companies-in-2023) - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Best Companies to Work For in France: Top 25 Companies in 2023 ](https://www.wearedevelopers.com/magazine/189-best-companies-to-work-for-in-france-top-25-companies-in-2023) - [Guide for Expats Living in France](https://www.wearedevelopers.com/magazine/305-guide-for-expats-living-in-france) - [Average Salary in France](https://www.wearedevelopers.com/magazine/269-average-salary-in-france) - [Average Salary in Paris](https://www.wearedevelopers.com/magazine/283-average-salary-in-paris)