Global Patient Safety Periodic Reporting Head

Ipsen is a dynamic and 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 and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences and Rare Diseases.

The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make the difference. We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions; leaders drawn by a purpose to make a direct impact through their work in people’s lives.

We offer employees a wealth of fulfilling challenges & growth opportunities, and the chance to contribute within a fast-moving organisation, an organisation that is genuinely game-changing.

Within the Global Patient Safety (GPS) Department, the GPS Periodic Reporting Head will be responsible for providing strategic and operational leadership to the GPS Periodic Reporting team.

Main responsibilities:

• Periodic Reporting Management (including Risk Management Plan Management)
• Drive the strategic planning and compliant execution of all Periodic Reporting activities including compilation of Periodic Safety Reports (PSRs) for developmental and marketed products.
• Represent GPS Operations in cross-functional groups and ensure that standards are met for pharmacovigilance (PV) audits and inspections.
• Lead and Manage Periodic Reporting Team Management
• Oversee all activities outsourced to external vendors contributing to PSR Medical Writing.
• Be responsible for ensuring that the Periodic Reporting activities and deliverables meet global PV regulations and requirements as well as Ipsen Standards.
• Ensure that internal Standard Operating Procedures (SOPs) covering Periodic Reporting activities are maintained up-to-date.
• Contributes to licensing agreements, clinical study documents and projects from a PSR perspective.
• EHS responsibilities

In order to be considered for this role you must have an advanced degree coupled with extensive experience within Drug Safety, Clinical Development and/or Pharmacovigilance.

Demonstrated experience of delivering PSRs and in safety data collection systems, safety reporting tools and safety databases. You will be a strong and committed leader, both operationally and strategically, with exceptional communication and influencing skills. If you feel that this could be the right next step for you, we would be delighted to engage with your application.