Pharmacovigilance (Pv)Specialist - Home Based

2 settimane fa

Bardi, Italia Randstad Italy A tempo pieno

The role of Pharmacovigilance (PV) specialist supports the International QPPV (Qualified Person for Pharmacovigilance Office) team to promote, maintain, and improve compliance with applicable regulatory and legal pharmacovigilance obligations in the EU and in international territories where the company operates.The role acts as the key liaison point between the company and the external contracted pharmacovigilance service providers, providing day-to-day operational support for PV system oversight, assisting in collecting information on countries, affiliates, and PV partners to support global expansion activities, and supporting collaboration with Global Regulatory Affairs and Drug Safety colleagues to align global expansion activities and local QPPVs with PV requirements.SalaryReimbursement annual: ******€ - ******€Experience2 yearsQualifications1+ years of experience as PV SpecialistAcademic background in pharmacovigilance, regulatory affairs or life scienceStrong organizational and communication skillsWillingness to learn and ability to manage multiple tasks in a dynamic environmentProficiency in Microsoft Office; familiarity with budget tracking systems is a plusFluency in English, both written and spokenAbility to review service provider contracts and work effectively with service providersResponsibilitiesEnsure oversight of activities and interactions with internal departments and external business partners to support the International QPPV Office team in meetings, when required; set up meetings, prepare agendas and minutesProvide support to Geographic Expansion activities: management and implementation of change controls and action plans for PV activities; management of periodic oversight meetings with local QPPVs and PV partners; perform other Geographic Expansion-related activities as appropriateServe as back-up for the PV Intelligence Coordinator: support maintenance of processes to ensure compliance with worldwide PV regulatory and legal requirements, assist in identifying actions in the marketing authorisation pre-submission phase and post-marketing approval based on local PV requirements, support the review of PV agreements highlighting local PV requirements within the agreementsAct as PSMF Administrator / back-up for PSMFs or equivalent documents: support preparation and ongoing maintenance of PSMFs or equivalent documents, help maintain the update schedule, ensure content is compliant with GVP Module II requirementsProvide support to the International QPPV Office for PV audits and inspections: assist with readiness, preparation, facilitation and follow-up; assist with development, management & implementation of corrective & preventative actions (CAPAs) arising from PV audits and inspectionsEqual Opportunity StatementLa ricerca è rivolta ai candidati ambosessi (L.********).Ti preghiamo di leggere l'informativa sulla privacy Randstad ( ai sensi dell'art.13 del Regolamento (UE) ******** sulla protezione dei dati (GDPR).#J-*****-Ljbffr

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