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About the Role
The Global Patient Safety Asset Lead, Rare Diseases represents Global Patient Safety (GPS) on Global Asset and Clinical Development Teams, serving as the primary contact for product-specific safety deliverables and issues. This role is accountable for safety surveillance and assessment, ensuring timely updates to the safety profile and appropriate risk management for safe and effective product use.
Responsibilities
- Ensure proactive safety and risk management for all assigned products.
- Implement proactive safety and risk management strategies, integrated with clinical development and life-cycle management plans.
- Ensure clinical development plans adequately address safety questions and deliver the safety strategy for approval.
- Support safety decision making for benefit-risk assessment.
- Ensure safety-based decisions are made with comprehensive evidence assessment.
- Provide safety expertise, strategies, and leadership to global filing teams for regulatory submissions, health authority questions, and periodic safety reports.
- 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.
- Lead signal detection and signal evaluation activities for assigned products.
- Provide strong safety representation at internal and external meetings.
- Contribute effectively in external interactions, including SMCs/IDMCs, regulatory authority meetings, and collaborations with external advisers or partnership companies.
- Contribute to the overall success of Global Patient Safety and Ipsen.
- Provide TA and product-specific training within GPS and company-wide, and for external vendors as required.
Requirements
- 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 files.
- Fluent in English.
- Additional European language such as French is preferable.
Skills
- Medical expertise
- Technical expertise
- Scientific expertise
- Safety data collection
- Safety data evaluation
- Medical interpretation
- Communication
- Leading Safety Teams
- Leading Cross functional Global Asset Teams
- Leading Clinical Development Teams
- Pharmacovigilance legislations
Location
- Global
Work Type
- Hybrid
Experience Level
- Director
Education Level
- MD
About the Company
- Ipsen is a mid-sized global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease, and Neuroscience.
- Supported by nearly 100 years of development experience, with global hubs in the U.S., France, and the U.K.
- Tackles areas of high unmet medical need through research and innovation.
- Passionate teams in over 40 countries bring medicines to patients in 88 countries.
- Champions human-centric leadership and fosters a culture of collaboration, excellence, and impact.
- Empowers individuals to be their true selves, grow, and thrive.
- Aims for sustainable growth, creating real impact on patients and society.
- A growing global specialty-driven biopharmaceutical company focused on innovation and specialty care.
- Aims to make a sustainable difference by significantly improving patients’ health and quality of life.
- Provides effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases.
Equal Opportunity
- We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”.
- The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities.
- When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions.
- Together we strive to better understand the communities we serve.
- If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.