Pharmacovigilance Specialist

Randstad Italy, for a client company in the pharmaceutical sector, is looking for a Pharmacovigilance Specialist.OverviewContractual Offer: €30‑40k. Full‑time. Remote working. The role supports the International QPPV (Qualified Person for Pharmacovigilance) office team to promote, maintain, and improve regulatory and legal pharmacovigilance obligations in the EU and international territories where the company operates. The specialist acts as the key liaison between the company and external contracted pharmacovigilance service providers, providing day‑to‑day operational support for PV system oversight and assisting in collecting information on countries, affiliates, and PV partners to support global expansion activities. The specialist collaborates with Global Regulatory Affairs and Drug Safety colleagues to align global expansion activities and local QPPVs with PV requirements.ResponsibilitiesEnsures oversight of activities and interactions with internal departments and external business partners to support the International QPPV Office team in meetings, when required.Sets up meetings, prepares agendas and minutes, when required.Provides support to geographic expansion activities, including management and implementation of change controls and action plans for PV activities, management of periodic oversight meetings with local QPPVs and PV partners.Performs other geographic expansion‑related activities, as appropriate.Serves as back‑up for the PV intelligence coordinator to support the maintenance of processes to ensure compliance with worldwide PV regulatory and legal requirements and to address any necessary changes in a timely and appropriate manner.Assists in coordinating the ongoing standard PV intelligence process; promotes awareness and contributes to continuous improvement of the PV intelligence process.Performs basic ad‑hoc PV intelligence searches to support geographic expansion.Assists in identifying actions to be implemented in the marketing authorisation pre‑submission phase and following post‑marketing authorisation approval based on local PV requirements, including but not limited to the local Pharmacovigilance System Master File (PSMF), local Qualified Person Responsible for Pharmacovigilance (QPPV), local Risk Management Plan/periodic reports.Identifies actions to be implemented in marketing authorisation