Job Description

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.


As

Global Patient Safety Regional EU Manager

, you 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.

L

iaise 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

This requires ability to evolve in a matrix environment, good pharmacovigilance expertise, including a comprehensive appreciation of pharmacovigilance legislation globally.

Main Responsibilities:

Oversight on affiliate activities for acquisition of safety data

Have an oversight and report on:

Direct reporting of safety information to Ipsen affiliates (such as call centres, 24/7, Health Authority cases, etc.) Local documentation, triaging, quality control, follow-up and reconciliations activities Local websites and digital media sponsored by Ipsen

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

Develop and maintain Service Level agreement (SLA) between Ipsen affiliate & GPS Monitor compliance to the PV agreement (PVA) in place between the commercial partners and GPS/affiliates Monitor compliance to regulatory reporting of ICSR, PSUR and other safety reports

Processes expert for questions and training for audits and inspections, and for driving best practice

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 For all audits and inspections, provide the appropriate support to affiliates

Build robust relationships with partners and other Ipsen functions

Liaise with all functions including commercial partner and other Ipsen functions

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 Have 1:1 meeting with affiliates to discuss the results from the monthly report, status of various regulatory commitments and any ongoing issues

In order to be considered for this role you must have:

healthcare professional degree such as doctor, pharmacist.

Strong 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 working with affiliates in different geographies

Prior experience with regulatory authority inspections and internal audits

Ability to handle contradictory information and make sense of complex systems. Ensuring compliance, regulatory reporting, and follow-up on CAPAs demands a strong culture of accountability across multiple stakeholders.

English's fluency

This is a short term contract of 6 months.

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