Requirements: English
Company: PharmaLex
Pharmalex is growing! As a result, we are looking fora PV Manager in Italy to lead projects. We are looking for a strongPV Specialist who is looking for a step up into an oversight role.Main responsibilities: - Set up and manage the localpharmacovigilance system - Local Literature Search - Local ICSRManagement - PV Intelligence Screening - Local PSMF Maintenance -Setting up local Organized Data Collection - Local PVA Management -Local adaptation and submission of PSUR / RMP - Local signaldetection - Implementation of additional Risk Minimization Measures- Reviewing materials relating to local post-authorization safety -Participate in PV-relevant audits and inspections - Attend regularmeetings according to project meeting schedule - Provide monthly PVreport on status of local PV system in the country/ies - Ensure PVtraining of affiliate employees, service providers and ThirdParties - Close cooperation with the global PV system of the clientas well as related global and local departments and functions -Issue, review and maintain pharmacovigilance procedures (i.e.Standard Operating Procedures, Working Practices) related to thelocal tasks in connection with client procedures - Closecooperation with the respective Deputy and providing the Deputywith information on relevant current PV activities - Deputy isassuming responsibility in case of planned or unplanned absence -The employee agrees to take over primary listed tasks andresponsibilities in other service lines, project managementactivities as client contact point and additional reasonable tasksthat align with their abilities, qualification and training, ifrequired Education and experience required - University degree inLife Science is desirable but not essential - Several yearsexperience and profound knowledge in the field of pharmacovigilance- Expertise, experience and knowledge regarding relevantlegislative and non-legislative guidelines on pharmacovigilanceMinimum Skills, Knowledge and Ability Requirements - Demonstrableability in leading, mentoring, managing and motivation of staff(team leads). - Ability to train and support junior/new colleaguesin daily activities; ability to lead small project with clearlydefined scope. - Ability to manage internal and external (client)relationships on operational / day-to-day working level as well asclient''s team lead level. - Good communication skills (written andverbally); capability to communicate issues and propose appropriatesolutions to decision makers. Good presentation skills. - Englishbusiness fluent & Italian.