GPS Regional EU Manager (fixed-term contract)

Title:

GPS Regional EU Manager (fixed-term contract)

Company:

Ipsen Innovation (SAS)

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram .

Job Description:

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 r epresentative.
• 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

O versight 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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