Individual Case Safety Reports (ICSR) Manager, Global Patient Safety Groupe Talents Handicap

L'entreprise IPSEN Pharma recherche actuellement des profils :

Are you ready to lead and innovate in a dynamic, patient-focused biopharmaceutical company?

Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients' health and quality of life, providing effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases.

Why Ipsen?

Patient-Focused: The patient is at the heart of everything we do, and improving their outcomes is the deliverable of every strategy.

Employee Care: We care for our employees, who are the ambassadors making a real difference.

Bold Leadership: We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions.

Growth Opportunities: We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization.

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 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

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 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
• Fluent in English

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