Global Patient Safety Senior Scientist

Title:

Global Patient Safety Senior Scientist

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 (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:

• Bachelor’s 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.