Senior Drug Safety Manager

1 settimana fa


Lazio, Italia Jr Italy A tempo pieno

col-wideJob Description: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 projectsActs as Project Managerfor assigned projects/contracts and provides the PV & Safety Director withregular updatesOversees project phasesand delivers against milestones on budget and on timeSupervises and trainsjunior staff, with a direct reporting line or according to a functionalrelationshipParticipates inworkflow development and strategic planning for PV ServicesDevelops and implementsSafety & Project Plans and Safety Management Plans for Project/Clientspecific AE workflows and ServicesUpdates 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 projectEnters/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 ClientPrepares and revisesSafety Data Exchange Agreements/PV AgreementsAssists the PVphysician in the Signal Detection/Management processAssists in thedevelopment of new standard operating procedures and work guidance and/orreview Clients SOPs, if applicable, to ensure full complianceAssists in ensuringaudit/inspection readinessEnsures tracking ofcompliance metricsAssists in identifyingand up following up corrective action plans arising from audits and inspectionsParticipates intraining development programs for cross-functional personnel and externalgroups in drug safety principles and practicesAssists the PVPhysician in the development of Study Protocols, IBs, IMPDs, RMPsMaycover the role of QPPV and Deputy and Italian Local Contact Person for PVBAKROUND & 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 screeningEnglish, Very goodGVPRegulatory guidelinesworldwideRegulatorynorms applicable to Pharmacovigilance#J-18808-Ljbffr



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