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Pharmacovigilance Specialist
4 settimane fa
Randstad Italy, for a client company in the pharmaceutical sector, is looking for aPharmacovigilance SpecialistContractual Offer: 30-40K.Working Hours: full time.Location: remote working.Brief Description:The role of Pharmacovigilance (PV) specialist supports the International QPPV (Qualified Persona for Pharmacovigilance Office team to promote, maintain, and improve with the applicable regulatory and legal pharmacovigilance obligations in the EU and in International Territories where the Company operates.The role acts ad the kay liaison point between the Company and the external contracted pharmacovigilance services 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.Responsabilities of the position:Ensures oversight of activities and interactions with internal departments and external business partners to:- support the International QPPV Office team in meetings, when require;- set up meetings, prepare agendas and minutes, when required;- provides support to Geographic Expansion activities to: management and implementation of change controls and actions plans for PV activities, management of periodic oversight meetings with local QPPVs and PV Partners;- perform 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;- assist in coordinating the ongoing standard PV intelligence process;- promote awareness and contribute to continuous improvement of the PV intelligence process;- perform basic ad-hoc PV intelligence searches to support Geographic Expansion;- assist in identifying actions to be implemented in the marketing authorisation pre-submission phase and following post-marketing authorization approval based on local PV requirements including but not limited to local Pharmacovigilance System Master File (PSMF), local Qualified Person Responsible for Pharmacovigilance (QPPV), local Risk Management Plan/periodic reports. In addition, identify actions to be implemented in marketing authorisation
