Global Patient Safety Senior Physician @ Ipsen

  • TypeFull Time
  • RoleDoctor
  • SectorClinical
  • SeniorityManagerial
  • LocationUK

Main responsibilities and tasks

This requires effective medical, technical and scientific expertise in safety data collection, evaluation, medical interpretation and communication.

  • 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.
  • Act as a 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).
  • Support the risk management activities for the respective TA products, ensuring high quality safety input for all benefit-risk assessments.

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 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 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
  • 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, 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 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
  • Provide relevant subject matter expertise as required for audits and inspections, including any necessary pre-work in preparation for the audit/inspection, interviews with auditors/inspectors, as required, and follow-up on any subsequent actions and CAPAs

Lead a team of safety physician and safety scientists who share the work for assigned products (if required)

  • Takes line management responsibility for a team of safety scientists and physicians who share the work for the assigned products. The accountability of scientists is focused on the integrated assessment of safety information from multiple sources, the accountability of physicians is the assessment of safety information to determine any impact on the safety profile to propose actions.
  • Training, mentoring and development of the team and empowerment for successful contribution to crossfuntional teams
  • Implementation of HR policies

Experience / Qualifications

  • MD, with several years of clinical experience exercising medical judgment as a physician
  • Minimum: 5 years of PV experience
  • Ideally of 10 years of industry experience in either clinical development or pharmacovigilance
  • Fluent in written and spoken English
  • 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
  • Prior experience with NDA/BLA or equivalent regulatory submissions, or experience working in a Regulatory Agency reviewing submission file
  • Ideally prior team management experience

Required Competencies

  • Competent medical judgment in safety decision-making
  • Competent team player with excellent networking and influencing skills
  • Ability to prioritise own workload, work under pressure and achieve strict timeline targets
  • Excellent verbal and written communication skills
  • Problem-solving approach – solution- and results-orientated
  • Team management and leadership skills

Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l’orientation sexuelle, de l’origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l’appartenance à un syndicat.