Global Senior Safety Physician Migraine

Job description

Title: Global Senior Safety Physician Migraine Company: Ipsen Biopharm Ltd About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: 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, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram. Job Description: 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 The Global Patient Safety Asset Lead, Migraine 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, and integrated with clinical development and life-cycle management plans for milestone decisions. Ensure guideline/regulatory compliance and that clinical development plans/life-cycle management plans adequately address the safety questions and deliver the safety strategy for approval by safety governance. Lead the development and maintenance of the Risk Management Plan, signal plan, benefit-risk framework and associated risk minimisation activities for assigned products, as applicable. Support safety decision-making for benefit-risk assessment Ensure that safety-based decisions for benefit-risk assessment are taken in the knowledge of a comprehensive assessment of all available evidence and are data driven. Provide safety expertise, strategies and leadership to global filing teams for all safety components of regulatory submissions, health authority safety 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, cross-functional teams and partners, as applicable under pharmacovigilance agreements. Lead signal detection and signal evaluation activities for assigned products, including assessment of potential impact on Reference Safety Information and associated regulatory actions. Collaborate closely with Global Drug Development, Medical Affairs and relevant study teams on the safety of patients participating in clinical studies, including Data Safety Monitoring Boards, additional risk minimisation measures and publication strategy. 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 Work collaboratively with safety scientists and provide TA- and product-specific training within GPS, more widely within the company and for external vendors as required. Provide relevant product and subject-matter expertise as required for audits and inspections, including preparatory work, interviews with auditors/inspectors, and follow-up on subsequent actions and CAPAs. 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 #LI-HYBRID 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. This means we also want to help you perform at your best when applying for a role with us. 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.