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About the Role
Represent Global Patient Safety (GPS) as a member of the Global Asset Team and Clinical Development Team for assigned products. Accountable for safety surveillance and assessment of integrated safety information to ensure timely proposal of safety profile changes and appropriate risk management actions 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 guideline/regulatory compliance and that clinical development plans/life-cycle management plans adequately address safety questions.
- Lead the development and maintenance of the Risk Management Plan, signal plan, benefit-risk framework and associated risk minimisation activities.
- Ensure safety-based decisions for benefit-risk assessment are data driven.
- Provide safety expertise, strategies and leadership to global filing teams for regulatory submissions, health authority safety 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.
- Lead signal detection and signal evaluation activities, 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 patient safety in clinical studies.
- 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, regulatory authority meetings, and interactions with external advisers or opinion leaders.
- Work collaboratively with safety scientists and provide TA- and product-specific training within GPS, the company, and for external vendors.
- Provide relevant product and subject-matter expertise for audits and inspections, including preparatory work, interviews, and follow-up on actions and CAPAs.
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
- Proactive safety and risk management
- Risk management strategies
- Clinical development
- Life-cycle management
- Guideline/regulatory compliance
- Risk Management Plan development
- Signal plan development
- Benefit-risk framework development
- Risk minimisation activities
- Benefit-risk assessment
- Safety expertise
- Safety strategies
- Regulatory submissions
- Health authority safety questions
- Periodic safety reports (PSURs, PBRERs, DSURs)
- Signal detection
- Signal evaluation
- Reference Safety Information
- Regulatory actions
- Data Safety Monitoring Boards
- Risk minimisation measures
- Publication strategy
- Safety representation
- Training
- Audit and inspection support
Location
- U.S.
- France
- U.K.
Work Type
- Hybrid
Experience Level
- Senior
Education Level
- MD
About the Company
- 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!
- 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.
- 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.
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.