Company: Ipsen Biopharm Ltd
Job Description:
Ipsen is a dynamic and 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 and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences and Rare Diseases.
The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make the difference. We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions; leaders drawn by a purpose to make a direct impact through their work in people's lives.
We offer employees a wealth of fulfilling challenges & growth opportunities, and the chance to contribute within a fast-moving organisation, an organisation that is genuinely game-changing.
Global Patient Safety Physician Rare Diseases
will support the Global Patient Safety Therapeutic Area (TA) Leaders with medical and scientific analyses, data reviews, signal management and risk assessment activities, evaluation of product quality issues and emerging safety issues, including contribution to safety documents.
Main Responsibilities: Ensure proactive safety and risk management for all assigned products Accountable for the conduct of safety surveillance and assessment of integrated safety information Support safety decision-making for benefit-risk assessment Ensure effective proactive continuous management of the safety profile for assigned development compounds and marketed products Act as a member of the Global Product Teams and Clinical Development Teams for one or more products. Ensure up-to-date oversight of the emerging safety profile for all TA products Support the risk management activities for the respective TA products, ensuring high quality safety input for all benefit-risk assessments. Provide strong safety representation at internal and external meetings where safety issues are considered, and/or safety decisions are made This requires effective medical, technical and scientific expertise in safety data collection, evaluation, medical interpretation and communication.
In order to be considered for this role you must be a
physician
with proven clinical ability exercising medical judgment as a physician coupled
with strong experience
in
either clinical development or pharmacovigilance ideally in Rare Diseases.
Prior experience with FDA/EMA or equivalent regulatory submissions , or experience working in a Regulatory Agency reviewing submission files or clinical trial applications.
You will have
exceptional leadership and influencing skills.
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. #J-18808-Ljbffr