Functieomschrijving 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. Responsabilit 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 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 Support the review of PV agreements, highlighting where local PV requirements should be reflected within the agreements Serves 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 Help maintain the schedule of updates and data requirements for the PSMFs or equivalent documents Ensure 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 Provides 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 Functie-eisen 1+ years of experience as Specialist in PV Academic background in pharmacovigilance, regulatory affairs or life science Strong organizational and communication skills. Willingness to learn and ability to manage multiple tasks in a dynamic environment. Proficiency in Microsoft Office tools, familiarity with budget tracking systems is a plus. Fluency in English, both written and spoken Ability to review service provider contracts, and work effectively with service providers. La ricerca è rivolta ai candidati ambosessi (L.903/77). Ti preghiamo di leggere l'informativa sulla privacy Randstad (https://www.randstad.it/privacy/) ai sensi dell'art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR). vetrinabakeca