Global Asset Safety Lead

il y a 4 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 Asset Safety Lead Oncology **is representing **Global Patient Safety** **(GPS)** team and reporting to the Head of GPS Oncology, is accountable for:

- Accountable for the conduct of safety surveillance and assessment of integrated safety information
- Ensure effective proactive continuous management of the safety profile for assigned development compounds and marketed products
- Support the risk management activities for the respective Therapeutic Area (TA) products, ensuring high quality safety input for all benefit-risk assessments.

In this role your primary focus will be:
**Ensure proactive safety and risk management for all assigned products**
- Through an ‘Integrated Safety Sciences’ collaborative approach, implement proactive safety and risk management strategies
- Lead the development of the Risk Management Plan for assigned products as applicable

**Support safety decision-making for benefit-risk assessment**
- Ensure that all safety-based decisions for benefit-risk assessment are taken in the knowledge of a comprehensive assessment of all available data
- Provide medical support (and leadership as delegated by the respective GPS TA Leader) for all safety components of regulatory submissions

**Ensure up-to-date oversight of the emerging safety profile for all TA products**
- Ensure continuous assessment of all new safety information, through the ‘Integrated Safety Sciences’ collaborative approach
- Lead signal detection and signal evaluation activities for assigned products

**Provide strong safety representation at internal and external meetings where safety issues are considered, and/or safety decisions are made**

**Contribute to the overall success of Global Patient Safety and Ipsen**
- Provide TA and product-specific training within GPS and more widely within the company and for external vendors as required

**Lead a team of safety physician and safety scientists who share the work for assigned products (if required)**
- Takes line management responsibility for a team of safety scientists and physicians who share the work for the assigned products.

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