Global Patient Safety Regional Manager

il y a 5 jours

BoulogneBillancourt, France Ipsen Pharma (SAS) Temps plein

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.

The **Global Patient Safety Regional Manager **contributes to a strong oversight of all Pharmacovigilance activities ensuring to the robustness of the Ipsen Pharmacovigilance System performed in the region by Ipsen affiliates and by commercial partners acting as affiliate

**Main Responsibilities**:

- Actively support the Ipsen Affiliate Pharmacovigilance Offices, to deliver the Ipsen Pharmacovigilance System, and associated quality system.
- 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.
- 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.
- This requires ability to evolve in a matrix environment, good pharmacovigilance expertise, including a comprehensive appreciation of pharmacovigilance legislation globally.

**Oversight on affiliate **activities for acquisition of **safety data***
- Direct reporting of adverse events to affiliates (call centers, 24/7, Health Authority cases, etc.)
- Local documentation, triaging, Quality Control, follow-up and reconciliation***

**Oversight on actions **taken by affiliates and **commercial partners **acting as affiliates/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***

**Build robust relationships **with partners and other **Ipsen functions***

**Affiliate / commercial **partners Interactions and **reporting***

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