Global Patient Safety Asset Lead, Rare Diseases

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 Leadershi p: 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

The Global Patient Safety Asset Lead, Rare Diseases is:

• Representing Global Patient Safety (GPS) as a member of the Global Asset Team and Clinical Development Team for one or more products, as required and as delegated by the respective GPS TA Leader, and as such be the contact person for relevant safety-related deliverables, issues and questions in relation to this (these) product(s).
• Accountable for the conduct of safety surveillance and assessment of integrated safety information, to ensure the timely proposal of changes to the safety profile and appropriate risk management and risk minimization actions, in order to warrant the safe and effective use of Ipsen product in development projects and on the market.

This requires effective medical, technical and scientific expertise in safety data collection, evaluation, medical interpretation and communication. Ideally, requires also experience in leading Safety Teams and Cross functional Global Asset Teams and Clinical Development Teams.

Main Responsibilities

Ensure proactive safety and risk management for all assigned products

• Implement proactive safety and risk management strategies, agreed cross-functionally with asset team colleagues for assigned products, integrated with clinical development and life-cycle management plans for milestone decisions
• Ensure that clinical development plans/life-cycle management plans adequately address the safety questions and deliver the safety strategy for approval by safety governance

Support safety decision making for benefit-risk assessment

• Ensure that all safety-based decisions for benefit-risk assessment are taken in the knowledge of a comprehensive assessment of all available evidence
• Provide safety expertise, strategies and leadership to the global filing teams for all components of regulatory submissions, health authority questions, and periodic safety reports (PSURs, PBRERs, DSURs)
• Contribute effectively to internal interactions and cross-functional teams

Ensure up-to-date oversight of the emerging safety profile for all TA products

• Ensure continuous assessment of all new safety information, in collaboration with the Safety Team and Cross functional Teams
• Lead signal detection and signal evaluation activities for assigned products

Provide strong safety representation at internal and external meetings where safety issues are considered, and/or safety decisions are made

• Contribute effectively in external interactions, e.g., SMCs/IDMCs; preparation of the medical safety aspects for, and attendance at, regulatory authority meetings; interactions with external advisers or opinion leaders; collaboration with colleagues from partnership companies for co-development or co-marketing etc.

Contribute to the overall success of Global Patient Safety and Ipsen

• Provide TA and product-specific training within GPS and more widely within the company and for external vendors as required

Qualifications

• MD, with several years of clinical experience exercising medical judgment as a physician
• Experience in leading Clinical Development Teams is ideal
• Pharmaceutical industry experience in clinical development
• Experience in leading Cross functional Global Product Teams, Safety Teams and Clinical Development Teams.
• Knowledge of product development processes and experience of cross-functional teamwork
• Working knowledge of pharmacovigilance legislations worldwide
• Prior experience with NDA/BLA or equivalent regulatory submissions, or experience working in a Regulatory Agency reviewing submission file
• Fluent in English, additional European language such as French is preferrable

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