A career is an ongoing journey of discovery: our 50,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Your role: The Head of GPS Region-EMEA (Regional Head) is directly accountable for management of all patient safety staff in the affiliates and Shared Service Centers (SSCs) within their designated region. In order to ensure full compliance with all relevant global and local regulatory requirements, internal company standards and best practices in the pharmaceutical industry for drug safety management the Regional Head is accountable to ensure well-functioning local PV systems in accordance with the global PV system. This includes continuous exchange with the other functions within GPS and key stakeholder functions such as Medical Affairs, Research and Development, Regulatory Affairs, Quality Assurance, Global Clinical Operations, Global Operations, Commercial functions and other local functions as required. This includes: Implementing and supporting an effective resource-efficient business operating model for local and regional drug safety activities, in line with international requirements, best practice and global drug safety company standards and processes. Accountability for ‘inspection-readiness for pharmacovigilance inspections of affiliates and SSCs in the respective territory. Driving of continuous improvements in all drug safety related matters by considering new technology platforms, tools and changes in the company settings and external environment. Actively contributing in relevant industry associations/communities to shape the regulatory environment according to company needs. Activities as direct superior of the Heads of Local Patient Safety in China, Japan, Local patient Safety Officers (LDSOs), Shared Service Center Managers (SSCM) and Expert Networks (i.e. PV Compliance, PDCS): Performance and talent development of direct and indirect staff in line with global programs (including recruiting, coaching, on-boarding, developing, performance management and appraisals of in the Regional Hub(s), to drive the enhancement of drug safety capabilities in the regional hubs and affiliates.
Who you are:
- Experience in pharmaceutical industry (5-10 years), thereof at least 5 years in pharmacovigilance functions at local and preferably at international level
- Experience in people, process and project management
- Knowledge of and experience with worldwide regional and local regulatory pharmacovigilance legislation
- Knowledge of and experience with GxP, especially Good Pharmacovigilance, Good Clinical, Good Manufacturing and Good Distribution Practice
Good understanding of drug development and life-cycle management of medicinal products, medical devices and combination products
What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!