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

About The Role

Within the Global Patient Safety (GPS) department, the ICSR Manager is a key contributor in the Individual Case Safety Reports (ICSRs) management.

You Will

• Manage all ICSR topics with respect of the regulatory guidelines and Ipsen standards in ensuring ICSR readiness for quality and distribution under the regulatory and internal timelines.
• Work in close collaboration 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 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 the GPS Therapeutic Area team to establish a robust TA case corrections process and ensure good communication with ICSR Vendor.
• Be responsible for maintaining up-to-date and accurate 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 ICSR activities.
• Participate in the writing and updating of the documents and 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 and external providers.
• Coordinate outsourced activities.

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 delivering ICSR reports.
• 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 and literature screening.
• Knowledge of Safety evaluation, MedDRA, PV regulations.
• Proficient user of modern IT and Office software.
• Fluent in English.