Production Manager - Newcastle - CDI F / H

Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care.

We aim to make a sustainable difference by significantly improving patients’ health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases.

The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make the difference. We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions; leaders drawn by a purpose to make a direct impact through their work in people’s lives.

We offer employees a wealth of fulfilling challenges & growth opportunities, and the chance to contribute within a fast-moving organisation, an organisation that is genuinely game-changing.

Job Title: Global Patient Safety MEA Eurasia Regional Lead

The Global Patient Safety MEA Eurasia Regional Lead oversees all Pharmacovigilance activities contributing to the robustness of the Ipsen PV System performed in the region Middle East Africa / Maghreb / Eurasia (including Saudi Arabia, Russia, Kazakhstan, Ukraine, and CIS countries) by Ipsen affiliates and by commercial partners acting as affiliates.

Main Responsibilities:

1. Oversight on affiliate activities for acquisition of safety data:

Actively support or ensure appropriate support to 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.

1. Oversight on actions taken by affiliates and commercial partners acting as affiliates / local PV representative for safety communication, risk management, and risk minimization:

Provide support and expertise for all pharmacovigilance staff and activities in the region, ensuring that processes are comprehensive, embedded in the cross-functional and global-local environment.

1. Processes expert for questions and training for audits and inspections, and for driving best practice.
2. Build robust relationships with distributors, partners, and other Ipsen corporate functions to ensure information flow.
3. Affiliate / commercial partners interactions and reporting:

Liaise with Commercial Partner acting as affiliates and / or as MAH to ensure compliance and performance of the PV services delivered by these commercial partners.

1. Manage the GPS Regional manager(s).
2. Travel is to be expected within this role, as business needs require.

In order to be considered for this role you must have significant and relevant experience in the pharmaceutical patient safety function including project and people management in a matrix environment.

Demonstrating a value-add capability and mindset to provide strong direct global leadership / project management. Strong experience of working with affiliates in different geographies.

You will have exceptional leadership and influencing skills. If you feel that this could be the right next step for you, we would be delighted to engage with your application.