Local Specialist Safety Officer – Italy

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.

Exceya is looking to collaborate with a Freelancer Local Specialist Safety Officer (Pharmacovigilance), full-time (approximately 140 hours per month), based in Italy. The position is full remote. Excellent knowledge of English and local language are required for this role.

The role:

The Local Specialist Safety Officer is Accountable for ensuring Pharmacovigilance systems, operations and procedures are in place within the local organization for all territories assigned to the Affiliate. They are the primary contact for pharmacovigilance at the Affiliate and the nominated contact person for pharmacovigilance (“Local QPPV” equivalent) as notified to the local Health Authorities. They are also responsible for Medical Information at the affiliate

Responsibilities:

• Supports the Country Safety Head in country related PV activities.
• Deputizes for the CSH in times of planned or unplanned absence of the CSH.
• Is nominated as deputy local Responsible Person for Pharmacovigilance (RPP/QPPV) for the CHC products where applicable per national regulations.
• Supports the CSH in ensuring that local PV activities in the assigned country are performed in compliance with the Global PV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of CHC products on the market in the assigned country.
• Builds close and robust relations/collaboration with the in-country partner functions, including but not limited to Medical, Regulatory, Quality, Commercial, Legal, and Country Manager.
• Supports the maintenance of local quality documents owned by PV to include documented reviews, gap assessments and revisions as per global requirements.
• Supports the maintenance of the local PV System Master File for the assigned country as required and in accordance with local regulations and the global standards.
• Monitors continuously in-coming communication to ensure the detection and appropriate management of in-coming PV data (ICSRs and other safety related information) to report them in timely manner to Global PV Operations and subsequently to external stakeholders, such as HAs, partners.
• Handles appropriately local periodic reports, including periodic safety reports (PSRs) and periodic reviews, and contribute together with Global PV, Clinical Operations and RA departments to the planning for PSRs.