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Pv Specialist- Portugal
4 semanas atrás
.Our team members are at the heart of everything we do.
At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose.
If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere.
Apply todayJob DetailsPharmalex is recruiting for a talented Sr PV Specialist to join our team in Portugal
We are looking for a fluent Portuguese speaker with 1-2 years experience as a PV Specialist/Drug Safety Associate who will be dedicated to our world-class pharmaceutical partner's project.
This is a remote-based position that can be hired in Portugal.Set up and manage the local pharmacovigilance systemLocal Literature SearchLocal ICSR ManagementSetting up local Organized Data CollectionLocal PVA ManagementLocal adaptation and submission of PSUR / RMPImplementation of additional Risk Minimization MeasuresReviewing materials relating to local post-authorization safetyParticipate in PV-relevant audits and inspectionsAttend regular meetings according to project meeting scheduleProvide monthly PV report on status of local PV system in the country/iesEnsure PV training of affiliate employees, service providers and Third PartiesClose cooperation with the global PV system of the client as well as related global and local departments and functionsIssue, review and maintain pharmacovigilance procedures (i.E.
Standard Operating Procedures, Working Practices) related to the local tasks in connection with client proceduresClose cooperation with the respective Deputy and providing the Deputy with information on relevant current PV activitiesDeputy is assuming responsibility in case of planned or unplanned absenceReview protocols for local studies and define PV related processes for local study projects prior to their initiation, in order to ensure compliance with the pharmacovigilance requirements and company standardsMinimum RequirementsMinimum college level education required.
A diploma or degree with a concentration in Life Sciences is a strong asset; 1-2 years experience in Medical Information, Clinical Research or Drug Safety or equivalent and related experience in pharmacy or pharmaceutical fields; Knowledge of Pharmacovigilance industry including up to date knowledge of pharmacovigilance guidelines of Health Canada, US FDA, EMEA and ICH; Adaptability tochange and to learn new skills as required; Experience in the medical and/or pharmaceutical field(s), medical terminology is an asset; Fluency in English and PortugueseWhat Cencora offersBenefit offerings outside the US may vary by country and will be aligned to local market practice.
The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements