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 800 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.
To learn more about us, visit www.excelya.com
Your responsibilities will include, but are not limited to:
- Collection and processing of adverse events to the global company.
- Serving as the legally responsible employee towards the MOH in respect to safety requirements.
- Working as a point of contact with the MOH in regards to the new regulation and legislation.
- Managing the local pharmacovigilance team.
- Ensuring local processes and procedures are in place to clearly define pharmacovigilance responsibilities within the Affiliate in line with Global SOPs and local regulations.
- Ensuring a local tracking system is in place, to ensure timely submissions of adverse events to Global Pharmacovigilance (GPV), and of ICSRs and Periodic Reports to the Regulatory Authority.
- Monitoring the risk/benefit profile of local products and communicating changes or concerns to Global Pharmacovigilance (GPV) for evaluation.
- Communication with the reporters: company employees, external service providers, HCPs and more.
Minimum Requirements :
- Pharmacist degree - Mandatory
- At least 3 years of documented local PV experience
- Knowledge of working in an international/global organization
- Fluent English and Hebrew - Mandatory
- Knowledge and experience in Microsoft office
- Previous experience - Advantage
- Team Player
- Excellent interpersonal skills