descrizione del lavoro

We are experts in the Life Sciences industry & Technology.We are a long-standing partner for technology and expert service provider across Clinical, Regulatory, Quality, Pharmacovigilance and Medical Affairs domains. We help companies to gain the best business value through technology-enabled solutions and achieve excellence in business operations.Job Description PURPOSE: Assist thePharmacovigilance & Safety Director in the management of the RegulatoryBusiness PV projects and project teams for the delivery of high-qualityservices to Clients, in full compliance with the applicable PV Legislation,Client’s requirements and Regulatory Business Quality Standards. Requirements ACCOUNTABILITIES: Manages PV & Safetyprojects and/or staff allocated to those projects Acts as Project Managerfor assigned projects/contracts and provides the PV & Safety Director withregular updates Oversees project phasesand delivers against milestones on budget and on time Supervises and trainsjunior staff, with a direct reporting line or according to a functionalrelationship Participates inworkflow development and strategic planning for PV Services Develops and implementsSafety & Project Plans and Safety Management Plans for Project/Clientspecific AE workflows and Services Updates the PV archivewith the required documentation (either in paper or electronic) Performs theregistration of the Company on behalf of the Client in Eudravigilance whenrequired by the project Enters/reports ICSRsand SUSARs to Eudravigilance via EVWEB (only in case he/she has been trained bya certified person or after having completed the Eudravigilance course) Ensures the preparationand submission of PSURs and DSURs according to the relevant rules and thedeadlines agreed with the Client Prepares and revisesSafety Data Exchange Agreements/PV Agreements Assists the PVphysician in the Signal Detection/Management process Assists in thedevelopment of new standard operating procedures and work guidance and/orreview Clients SOPs, if applicable, to ensure full compliance Assists in ensuringaudit/inspection readiness Ensures tracking ofcompliance metrics Assists in identifyingand up following up corrective action plans arising from audits and inspections Participates intraining development programs for cross-functional personnel and externalgroups in drug safety principles and practices Assists the PVPhysician in the development of Study Protocols, IBs, IMPDs, RMPs Maycover the role of QPPV and Deputy and Italian Local Contact Person for PV BAKROUND & EXPERIENCE University Degree inScientific Subject (such as Chemistry, CTF, Biology….and similar) Atleast 5 years of experience in PV Operations, including case processing,Pharmacovigilance Agreement writing, literature screening English, Very good GVP Regulatory guidelinesworldwide Regulatorynorms applicable to Pharmacovigilance #J-18808-Ljbffr