Global Patient Safety Scientist Rare Diseases

il y a 4 jours

BoulogneBillancourt, France Ipsen Pharma (SAS) Temps plein

**This is a fixed-term contract, office-based (3 days a week) either in London or Paris.**

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 (GPS) Scientist, Rare Diseases**supports the GPS with safety surveillance scientist activities including scientific analyses, case reviews, data reviews & presentations, study team membership, clinical safety, supporting phase I - IV.

**Main Responsibilities**:

- Provide scientific review and interpretation of safety data for the preparation of aggregate reports such as Development Safety Reports (DSURs), Periodic Safety Update Reports (PSURs)
- Conduct signal detection activities, signal evaluation and risk assessment, and manage the process for the development and management of Risk Management Plans
- Work cross-functionally to ensure that Clinical, Franchise, Asset Team and Regulatory objectives are met by reports being submitted according to international regulatory requirements and Company objectives and timelines.
- Provide scientific expertise to the preparation of responses to internal and external questions relating to the safety of allocated products; this includes the management and monitoring of external vendors used to author such documents

In order to be considered for this role you must have an **advanced Clinical/Science degree (PharmD, MD or PhD)**coupled with **pharmacovigilance experience in pharmaceutical industry or CROs.**

**Ideally demonstrated experience in clinical development**and filling**Development Safety Reports (DSURs), Periodic Safety Update Reports (PSURs).**

You will have exceptional communication and influencing skills.

**English and French fluency is required**.

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