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Safety Scientist Oncology
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**Title**:
Safety scientist Oncology
**Company**:
Ipsen Pharma (SAS)
The Senior Safety Scientist is responsible for supporting the ongoing evaluation of the safety profile of assigned products within the Endocrinology and Oncology Therapeutic Area.
**Main responsibilities / job expectations**
- Collaborates effectively with the respective Safety Physicians in assigned projects and products
- Participate in the implementation of the Global Safety Strategy within the Endocrinology/Oncology TA
- Review and evaluate safety data from pre-clinical studies, clinical studies, literature and PV databases to establish the safety profile of assigned products
- Compile, interpret and present safety data to internal and external stakeholders
- Process, analyse and translate state-of-the art medical and biomolecular information
- Provide expertise on safety aspects of development projects
- Participate in the elaboration of the risk-benefit assessments of assigned products
- Provide strategic safety insights in relation to early clinical development programmes
- Support in the preparation of risk assessments and risk mitigation plans as well as safety components of clinical development plans
- Draft safety sections of Clinical Protocols and Study Reports
- Provide scientific input and/or review for periodic regulatory documents (PBRERs, DSURs) and safety aspects of Regulatory Authority submission documents
- Assist in the writing of safety sections of post-marketing documents (e.g. PSUR, CDS updates, RMP updates)
- Assist PV with the preparation of adverse event reporting plans, case entry and follow-ups
- Represent Patient Safety on cross-functional project teams for developmental or marketed products
- Communicate latest safety developments and data to the Ipsen organisation
- Determine and implement post-market surveillance (PMS) for medical device products
**EHS responsibilities**:
- Comply with applicable EHS regulations and procedures.
- Participate in the site's EHS performance by reporting risks, malfunctions or improvements
- Participate in mandatory EHS training
**Knowledge, abilities & experience**
Experience & qualifications:
- Master’s Degree in Natural Sciences
- 5+ years of experience within Patient Safety, Clinical Development and/or Pharmacovigilance
- Demonstrated hands-on experience of working with Pharmacovigilance
**Key Technical Competencies Required**
- Knowledge and understanding of Pharmacovigilance principles and regulations
- Ability to access, understand and process state-of-the-art medical and biomolecular information and content
- Excellent communication skills, both verbal and written (English)
