PRandstad Italy, for a client company in the pharmaceutical sector, is looking for a /ppbr/ppbPharmacovigilance Specialist /b /ppbr/ppbContractual Offer: /b30-40K. /ppbr/ppbWorking Hours: /b full time. /ppbr/ppbLocation: /bremote working. /ppbr/ppbBrief Description: /b /ppbr/ppThe 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. /ppbr/ppThe 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. /ppbr/ppbResponsabilities of the position: /b /ppbr/ppEnsures oversight of activities and interactions with internal departments and external business partners to: /ppbr/pullisupport the International QPPV Office team in meetings, when require; /liliset up meetings, prepare agendas and minutes, when required; /liliprovides 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; /liliperform other Geographic Expansion-related activities, as appropriate; /liliserves 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; /liliassist in coordinating the ongoing standard PV intelligence process; /lilipromote awareness and contribute to continuous improvement of the PV intelligence process; /liliperform basic ad-hoc PV intelligence searches to support Geographic Expansion; /liliassist 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 transfer and/or withdrawal; /lilisupport the review of PV agreements, highlighting where local PV requirements should be reflected within the agreements; /liliserves as the PSMF Administrator/back-up for the PSMFs or equivalent documents to: act as support or back-up for the preparation and ongoing maintenance of the PSMFs or equivalent documents, and the related documentation, in accordance with the assigned schedule; /lilisupport the ad hoc preparation of Summaries of PV system; /lilihelp maintain the schedule of updates and data requirements for the PSMFs or equivalent documents; /liliensure the content of the PSMFs, or equivalent documents, are compliant vs GVP Module II requirements by liaising with key contributors from all relevant global functions and/or with the Local applicable PV regulations; /liliensure the content of the PSMFs, or equivalent documents, are provided in a timely manner, collating the data, resolving queries and ensuring review, approval and release of the document as appropriate and per applicable procedures; /liliprovides support to the International QPPV Office for PV audits and inspections, including: assisting with the readiness, preparation, facilitation and follow-up of PV audits and inspections,assisting with the development, management implementation of corrective preventative actions (CAPAs) arising from PV audits and inspection /li /ulpbr/ppbRequired Knowledge, Skills and Abilities: /b /ppbr/pulli1+ years of experience as Specialist in PV; /liliAcademic background in pharmacovigilance, regulatory affairs or life science; /liliStrong organizational and communication skills; /liliWillingness to learn and ability to manage multiple tasks in a dynamic environment. /liliProficiency in Microsoft /li /ulpbr/ppbr/ppThe search is open to both male and female candidates (L.903/77). Please read the privacy policy pursuant to Article 13 of Regulation (EU) 2016/679 on data protection (GDPR) at /p