Global Asset Safety Leader Oncology

il y a 3 semaines

BoulogneBillancourt, France IPSEN Temps plein

**Title**:
Global Asset Safety Leader Oncology

**Company**:
Ipsen Pharma (SAS)

**Main responsibilities and tasks**
- Represent Global Patient Safety as a member of the Global Asset 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).
- Accountable for the conduct of safety surveillance and assessment of integrated safety information, to ensure the timely proposal of changes to the safety profile and appropriate risk management and risk minimization actions, in order to warrant the safe and effective use of Ipsen product in development projects and on the market.
- Ensure effective 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.
- Support the risk management activities for the respective TA products, ensuring high quality safety input for all benefit-risk assessments.

Ideally, requires experience in leading Safety Teams and Cross functional Global Asset Teams and Clinical Development Teams. Ideally, requires effective expertise in safety data collection, evaluation, medical interpretation and communication.

**Ensure proactive safety and risk management for all assigned products**
- Implement proactive safety and risk management strategies, agreed cross-functionally with asset 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
- Lead the development of the Risk Management Plan for assigned products as applicable
- Member of the Risk Minimisation Programme Team (leadership of this team may be delegated by the respective GPS TA Leader), 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 evidence
- Provide safety expertise, strategies and leadership to the global filing teams for all components of regulatory submissions, health authority questions, and periodic safety reports (PSURs, PBRERs, DSURs)
- Contribute effectively in internal interactions and cross-functional teams
- Deliver medical safety assessments as required, eg in the evaluation of the risk and impact of product quality complaints
- Ensure that the respective GPS TA Leaders, and thereby Ipsen senior management, are kept informed of any new data 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, in collaboration with the Safety Team and Cross functional Teams
- 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, additional risk minimization measures and publication strategy.

**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, 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

**Lead a team of safety physician and safety scientists who share the work for assigned products (if required)**
- Leads the Safety team of safety scientists and physicians who share the work for the assigned products.
- Training, mentoring and development of the team and empowerment for successful contribution to cross functional teams
- Implementation of HR policies

**Experience & Qualifications**:

- MD, with clinical experience exercising medical judgment as a physician
- Minimum: 7 years of PV experience
- Fluent in written and spoken English
- Experience in leading Cross functional Global Produc

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