Global Patient Safety Physician- Rare Disease

Title:
Global Patient Safety Physician- Rare Disease

Company:
Clementia Pharmaceuticals USA, Inc.

Job Description:
Do you have medical, technical and scientific expertise in safety data collection, evaluation and medical interpretation? As Global Patient Safety (GPS) Physician, focused in Rare Disease, you will ensure effective and proactive continuous management of the safety profile for assigned development compounds and marketed products, so that safety considerations reliably inform project decision-making, and all clinical development and life-cycle management safety milestones are met. You will be an active member of the Global Product Team and Clinical Development Team for one or more products, as required and as delegated by the respective GPS TA Leader, and as such be the contact person for relevant safety-related deliverables, issues and questions in relation to this (these) product(s). Additionally, you will support the risk management activities for the respective TA products, ensuring high quality safety input for all benefit-risk assessments.Your role will involve: Ensure proactive safety and risk management for all assigned products

• Through an ‘Integrated Safety Sciences' collaborative approach, implement proactive safety and risk management strategies, agreed cross-functionally with product team colleagues, for assigned products, integrated with clinical development and life-cycle management plans for milestone decisions
• Ensure that clinical development plans/life-cycle management plans adequately address the safety questions and deliver the safety strategy
• Lead the development of the Risk Management Plan for assigned products as applicable

Support safety decision-making for benefit-risk assessment

• Ensure that all safety-based decisions for benefit-risk assessment are taken in the knowledge of a comprehensive assessment of all available data
• Provide medical support (and leadership as delegated by the respective GPS TA Leader) for all safety components of regulatory submissions, health authority safety-related questions, and periodic safety reports (PSURs, PBRERs, DSURs)
• Contribute effectively in internal interactions and cross-functional teams

Ensure up-to-date oversight of the emerging safety profiles for all TA products

• Ensure continuous assessment of all new safety information, through the ‘Integrated Safety Sciences' collaborative approach
• Lead signal detection and signal evaluation activities for assigned products
• Collaborate closely with Global Drug Development and Medical Affairs on safety of patients participating in clinical studies including the operation of Data Safety Monitoring Boards
• GPS Product Leader role for the assigned product(s), ensuring appropriate medical safety input to all safety-related issues and questions

Provide strong safety representation at internal and external meetings where safety issues are considered, and/or safety decision are made

• Contribute effectively in external interactions, eg SMCs/IDMCs; preparation of the medical safety aspects for, and attendance at, regulatory authority meetings; interactions with external advisers or opinion leaders; collaboration with colleagues from partnership companies for co-development or co-marketing etc
• As delegated by the GPS TA Leader, provide medical safety expertise for due diligence activities, preparing an integrated safety assessment for consideration by senior management

Contribute to the overall success of Global Patient Safety and Ipsen

• Provide TA and product-specific training within GPS and more widely within the company and for external vendors as required

In return, you will bring:

• Medical Degree
• Physician with proven clinical ability exercising medical judgment as a physician
• Fluent in written and spoken English
• Industry experience in either clinical development or pharmacovigilance
• Knowledge of product development processes and experience of cross-functional team work
• Working knowledge of pharmacovigilance legislation
• Prior experience with NDA/BLA or equivalent regulatory submissions, or experience working in a Regulatory Agency reviewing submission file

Apply today to apply your knowledge and medical expertise on our global patient safety team!

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.