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Global Patient Safety Ta Leader Rare Disease
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**Title**:
Global Patient Safety TA Leader Rare Disease
**Company**:
Ipsen Pharma (SAS)
- **Lead the respective Therapeutic Area (TA) team within GPS, to ensure effective proactive medical safety strategies and continuous management of the safety profile for all development compounds and marketed products within the TA, so that safety considerations reliably inform project decision-making, and all clinical development and life-cycle management safety milestones are met.**:
- **As a core member of the Global Product Team and Clinical Development Team for all respective TA products, be the contact person for all safety-related deliverables, issues and questions in relation to these products.**:
- **Lead the risk management activities for the respective TA products and ensure high quality safety input for all benefit-risk assessments.**:
- **Ensure adequate resourcing and drug safety capabilities for all clinical and post-marketing product-related deliverables.**
**This requires effective medical, technical and scientific expertise in safety management and a thorough understanding of product strategy (including the viewpoints of other domains, such as development, commercialization, production, regulatory management).**
**Main responsibilities / job expectations**
- **Ensure proactive safety and risk management strategies are developed and implemented for all TA 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 for approval by safety governance
- Accountable for ensuring the development of the Risk Management Plan for all relevant products in the TA
- Lead the Risk Minimisation Programme Team, and ensure the evaluation of the effectiveness of risk minimisation measures
- ** 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 leadership for all safety components of regulatory submissions, health authority safety-related questions, and periodic safety reports (PSURs, PBRERs, DSURs)
- Contribute effectively in asset teams interactions and any cross-functional teams
- Deliver medical safety assessments as required, e.g. in the evaluation of the risk and impact of product quality complaints
- Ensure that Ipsen senior management are proactively kept informed of any new data / potential signal that might impact the benefit risk of Ipsen products.
- ** Ensure up-to-date oversight of the emerging safety profile 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 the TA 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 products in the TA, 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 decisions are made**
- Contribute effectively in external interactions, e.g. 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.
- Provide medical safety expertise for due diligence activities, and prepare an integrated safety assessment for consideration by senior management
- ** Leadership and line management of the TA team, and overall contribution to GPS vision and compliance**
- Drive effective performance management of employees within the TA team
- Ensure coaching, mentoring, training and development opportunities for employees within the TA team
- Prospectively assess the future workload demand for the TA, and work with the Head of GPS to define appropriate resourcing strategies to ensure access to the required safety skills and capabilities
- Ensure sustained full compliance with worldwide regulations within the TA team
- Provide TA and product-specific training within GPS and more widely within the company and for external vendors as required
- ** EHS**
- Promote an EHS dynamic within the teams for functioning of the EHS management system
- Participate in prevention of accidents at work by carrying out VMS
- Ensure the completion of mandatory EHS training
**
