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Job DetailsPharmalex is recruiting for a talented Sr PV Specialist to join our team in the DACH region! We are looking for a fluent German 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 ManagementPV Intelligence ScreeningSetting 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 schedule Provide monthly PV report on status of local PV system in the country/ies Ensure 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 standards.
Minimum 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 to change 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.
Full timeAffiliated CompaniesAffiliated Companies:Equal Employment OpportunityCencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
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