Global Patient Senior Safety Scientist
il y a 3 jours
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 Senior Safety Scientist** supports the Global Patient Safety Therapeutic Area with scientific analyses, case reviews, data reviews & presentations, signal management and risk assessment activities, evaluation of product quality issues and emerging safety issues, including contribution to safety documents, aggregate reports, RMPs and health authority requests, submission, interactions etc. for allocated asset/products, projects and activities.
**Main Responsibilities**:
- Provide scientific review and interpretation of safety data for the preparation of aggregate reports
- Provide scientific expertise during 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 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.
- Deliver efficient and timely review of clinical trial documentation (protocols, study reports, monthly reports of serious adverse events etc.)
- Provide requisite regular reports of safety data, including appropriate scientific data analysis, to support the MDD and the GPS TAL/Physician in efficient medical monitoring.
- Review clinical trials safety data throughout the clinical development programme
LI-HYBRID
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