Global Patient Safety Senior Scientist
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Job Location:
Monthly Salary:
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
Title:
Global Patient Safety Senior ScientistCompany:
Ipsen Biopharm LtdAbout 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 companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!
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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 (GPS) Safety Scientist is a key member of the Oncology team. As the Global Patient Safety Safety Scientist you support the GPS Therapeutic Area with safety surveillance scientist activities including scientific analyses case reviews data reviews & presentations study team membership clinical safety
Key Responsibilities:
Conduct scientific review and interpretation of safety data for aggregate reports including DSURs PSURs CTD modules and CCDS/labels.
Support regulatory submissions in line with the overall safety strategy including data analysis for responses to questions RMP & label proposals
Lead and conduct signal detection risk assessment evaluation and (develop) Risk Management Plans.
Monitor clinical trial safety data throughout development to identify medical concerns and ensure data quality for regulatory compliance.
Support GPS contributions to Patient Data Collection Systems (e.g. Patient Support Programs Market Research Programs) and Non-Interventional Studies.
Clearly present scientific and medical information both verbally and in writing.
Prepare responses to safety inquiries and manage relationships with external vendors.
Qualifications:
Bachelors degree in biologic or natural science or advanced degree (MSc PhD MPH PharmD etc.)
Strong experience in Specialty Care preferably Oncology
Extensive industry/pharmacovigilance experience
Strong experience in safety reports writing and safety signal management.
Strong experience in regulatory filing
Good knowledge of pharmacovigilance legislation
Fluency in English
If you feel that this could be the right next step for you we would be delighted to engage with your application.
Ipsen is committed to fostering a diverse and inclusive workplace where all employees feel valued and empowered. If you feel that this could be the right next step for you we would be delighted to engage with your application.
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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.Required Experience:
Senior IC
Key Skills
- Laboratory Experience
- Mammalian Cell Culture
- Biochemistry
- Assays
- Protein Purification
- Research Experience
- Next Generation Sequencing
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Flow Cytometry
About Company
Ipsen is a global biopharmaceutical company focused on innovation and specialty care to improve the lives of patients around the world.
