GPS Regional EU Manager (fixed-term contract)IPSEN

Ipsen est un groupe biopharmaceutique mondial de taille moyenne, spécialisé dans les médicaments transformateurs dans trois aires thérapeutiques : l'oncologie, les maladies rares et les neurosciences. Forts de près de 100 ans d'expérience en développement, avec des Hubs mondiaux aux États-Unis, en France et au Royaume-Uni, nous focalisons nos efforts là où les besoins médicaux non satisfaits sont importants, grâce à la recherche et à l'innovation.

Nos équipes passionnées, présentes dans plus de 40 pays, se concentrent sur l'essentiel et s'efforcent chaque jour d'apporter des médicaments aux patients dans 88 pays. Nous construisons un environnement de travail qui met en avant un leadership centré sur l'humain et favorise une culture de collaboration, d'excellence et d'impact. Au sein d'Ipsen, chaque individu est encouragé à être soi-même, à grandir et à s'épanouir aux côtés du succès de l'entreprise. Rejoignez-nous dans notre démarche vers une croissance durable, en créant un impact réel sur les patients et la société.

Pour plus d'informations, visitez notre site web à l'adresse https://www.ipsen.com et suivez nos dernières actualités sur LinkedIn et Instagram.

At Ipsen, we choose to focus on what matters most. Patients. Progress. Partnership. Yes.

We are looking for a Head of Safety Partnering to define and lead our global pharmacovigilance partnering strategy across a diverse commercial portfolio. This is a pivotal leadership role at the heart of how we collaborate, ensuring that strong partnerships translate into safe, compliant and impactful outcomes for patients worldwide.

Why this role matters

The Global Patient Safety Regional EU Manager will:

• Contribute to a strong oversight of all Pharmacovigilance activities ensuring to the robustness of the Ipsen PV System performed in Europe by Ipsen affiliates and by commercial partners acting as PV representative.
• Actively support the Ipsen Affiliate Pharmacovigilance Offices, to deliver the Ipsen Pharmacovigilance System, and associated quality system, such that all affiliate PV processes are efficient and cost-effective, consistent with Ipsen standards, and delivering full compliance with all regulatory authority requirements worldwide.
• Provide support and expertise for all pharmacovigilance staff and activities in the European region, ensuring that processes are comprehensive, embedded in the cross-functional and global-local environment.
• Liaise with Commercial Partner acting as PV representatives and /or as Marketing Authorisation Holders of Products owned by Ipsen, to ensure compliance and performance of the PV services delivered by these commercial partners

Main responsibilities

Oversight on affiliate activities for acquisition of safety data
Oversight on actions taken by affiliates and commercial partners acting as local PV representative for patient safety activities

• Act as a subject-matter expert to address any questions from Ipsen affiliate staff, from external partners or from local regulatory authorities regarding Ipsen PV processes, international PV regulatory requirements & local process management

Build robust relationships with partners and other Ipsen functions

• Liaise with all functions including commercial partner and other Ipsen functions such as medical affairs, regulatory affairs, medical information etc. to have an overview of processes impacting PV affiliate workflows

Affiliate / commercial partners Interactions and reporting

• Establish and maintain a monthly reporting from affiliate on all PV activities managed in-country, and from commercial partners operating in Europe

Qualifications

• Strong of experience in pharmaceutical industry / patient safety function
• Knowledge and experience of management of safety data collection and communication of safety issues
• Good working knowledge of pre- and post-marketing PV legislation
• Experience of cross-functional teamwork
• Experience of working with affiliates in different geographies
• Prior experience with regulatory authority inspections and internal audits
• Experience in translating legislation to internal processes
• Healthcare professional degree such as doctor, pharmacist.
• Fluent in written and spoken English

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