About The Role
The Global Asset Safety Lead works closely and collaboratively with the Asset Safety Lead to ensure a harmonised and consistent approach for the safety and risk management strategies across the entire clinical development programme.
You Will
- Represent the Global Patient Safety (GPS) as a member of the Global Asset Team and Clinical Development Team for one or more products
- Be the contact person for relevant safety‑related deliverables, issues and questions in relation to this (these) product(s)
- Ensure effective proactive medical safety strategies and continuous management of the safety profile for assigned products within the TA Neuroscience
Director Level
This is a director level role.
Main Responsibilities
- Provide leadership and expert safety oversight as a key member of the cross‑functional Asset Team
- Support clinical development of the product by leading the delivery of safety‑driven activities across the full development programme – from FIH studies through to regulatory submission – in close collaboration with cross‑functional Asset Team members
- 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 minimisation actions, in order to warrant the safe and effective use of Ipsen products in development projects and on the market
- Actively contribute to the cross‑functional working groups as the representative safety expert to ensure these considerations are taken into account during the clinical development of the product
- 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
- 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
- Clearly communicate and distil complex safety data into meaningful insights for decision‑makers
- 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
- Chair the PST/BRT if the Asset Safety Lead is unavailable, support B/R assessments and ensure the evaluation of the effectiveness of risk minimisation measures
- 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)
- Deliver medical safety assessments as required, e.g. 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, working in collaboration with the Asset Safety Lead
Qualification
- Doctor of Medicine (MD)
- Extensive clinical experience exercising medical judgment as a physician and several years of PV and/or clinical development experience
- Experience in leading cross‑functional global product teams, safety teams and clinical development teams
- Knowledge of product development processes and experience of cross‑functional teamwork
- Working knowledge of pharmacovigilance legislations worldwide
- Competent team player with excellent networking and influencing skills
- Ability to prioritise own workload, work under pressure and achieve strict timeline targets
- Problem‑solving approach – solution‑ and results‑orientated
- Prior experience with NDA/BLA or equivalent regulatory submissions, or experience working in a regulatory agency reviewing submission file
- Fluency in English
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