Global Patient Safety Senior Scientist

Overview

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.

• 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.

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, and clinical safety 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.

• Bachelor’s degree in biologic or natural science or advanced degree (MSc, PhD, MPH, Pharm
  
  D, 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.