Case Specialist / Lso (French And Spanish Speaker) Vaf 325

Case Specialist / LSO (French and Spanish speaker) Join our hub to oversee and work closely with our PV team to ensure compliance with regulatory standards and accurate safety data.
ResponsibilitiesCase Management & ReviewCollect and assess reports of adverse events from healthcare providers, patients, and healthcare systems.Perform medical review of safety reports, analyzing patient history, dosage, and the timing of adverse events.Query and conduct further assessments when necessary to clarify the nature of adverse reactions.Ensure quality control (QC) for post-marketing cases.Documentation & ComplianceCreate and maintain detailed case reports, ensuring accurate documentation in pharmacovigilance databases (Argus, SafetyEasy).Submit safety reports to regulatory agencies such as the FDA, EMA, and relevant national authorities.Ensure compliance with Good Pharmacovigilance Practices (GVP) and local regulatory requirements.Regulatory & Client CommunicationAct as the Local Safety Officer (LSO) on behalf of PLG clients in Spain, including acting as the Local Pharmacovigilance Person (LPPV) nominated to the authorities.Serve as point of contact with local regulatory authorities, including 24/7 availability as required.Stay updated with local regulatory requirements and conduct local regulatory intelligence screening.Support and contribute to PV activities performed by the Pharmacovigilance / Medical Information teams.Audits & InspectionsParticipate in audits and inspections.Contribute to action plans to maintain compliance with regulatory and company standards.Experience & QualificationsDegree in Pharmacy or Life Sciences.Minimum 3 years of experience in pharmacovigilance, focusing on post-marketing case processing and QC.Proven ability to meet deadlines and work efficiently under pressure.Experience in client communication related to PV matters.Knowledge of GCP and GVP.Hands-on experience with pharmacovigilance databases (e.g., Argus, SafetyEasy).Strong attention to detail, organization, and reliability.Knowledge of local Spain and international regulations.Proficiency in Microsoft Office (Word, Excel, PowerPoint).Experience with local case management activities (e.g., translation, data entry, QC, follow-up requests).Fluency in Spanish and French.
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