Global Patient Safety Scientist

Hobson Prior are currently working with a growing global specialty-driven biopharmaceutical company who are looking for a Global Patient Safety Scientist to join them on a permanent basis in France.
This position will be responsible for supporting the ongoing evaluation of the safety profile of assigned products within the Endocrinology and Oncology Therapeutic Area.

Job Responsibilities:

• Co-operates effectively with the respective Safety Physicians in assigned projects and products.
• Partake 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.

Key Skills:

• 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).

Requirements:

• Master's Degree in Natural Sciences.
• A minimum of 5+ years of experience within Patient Safety, Clinical Development and/or Pharmacovigilance.
• Demonstrated hands-on experience of working with Pharmacovigilance.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.