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Safety Specialist
Il y a 3 mois
Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.
We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 900 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.
For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
Key Activities :
This position is involved in many aspects of pharmacovigilance coordination and execution at the affiliate and will provide back-up support to the AHoPS as required. Patient Centricity:
- Provide interpretation and communicate impact of changes in local pharmacovigilance regulatory requirements to global Patient Safety team
- Feedback and influence local legislation consultations as appropriate Communication of Safety Information:
- Participate to local decision making in collaboration with AHoPS, global Patient Safety on communication of Safety Information to CPO and external & internal stakeholders,
- Communicate safety related issues and information that may be of relevance to the identification of potential safety signals to AHoPS in order AHoPS communicates such information to CPO, Patient Safety Therapeutic Area (TA) leads / qualified person responsible for pharmacovigilance in the European Union (EU QPPV) and local stakeholders.
Profile :
• Pharmacist
• Practical experience in pharmacovigilance is beneficial
• Basic understanding of drug safety regulations and obligations is beneficial
• Teamwork and ability to propose new ideas
• Ability to maintain confidentiality (especially on patient's records), quality and accuracy
• Good communication skills
• Good written and spoken English is essential
