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Case Specialist/LSO (French and Spanish speaker) VAF 325, Valladolid
ProductLife Group is seeking a dedicated
Case Specialist/LSO (French and Spanish speaker)
to join our hub. The role involves overseeing and working closely with our PV team to ensure compliance with regulatory standards and accurate safety data.Responsibilities
Case Management & Review:
Collect and assess reports of adverse events, perform medical reviews, query and conduct further assessments, and ensure quality control for post-marketing cases.Documentation & Compliance:
Create detailed case reports, maintain documentation in pharmacovigilance databases, submit safety reports to regulatory agencies, and ensure compliance with GVP and local regulations.Regulatory & Client Communication:
Act as the Local Safety Officer (LSO) and Local Pharmacovigilance Person (LPPV), act as point of contact with authorities, stay updated on local regulatory requirements, conduct regulatory intelligence screening, and support PV activities.Audits & Inspections:
Participate in audits and inspections, contributing to action plans for compliance.Experience and Qualifications
Degree in Pharmacy or Life Sciences.Minimum 3 years of pharmacovigilance experience, especially in post-marketing case processing and QC.Ability to meet deadlines and work efficiently under pressure.Experience in client communication related to PV.Knowledge of GCP and GVP.Hands-on experience with pharmacovigilance databases (e.G., Argus, SafetyEasy).Strong attention to detail, organization, and reliability.Knowledge of Spanish and international regulations.Proficiency in Microsoft Office.Experience with local case management activities such as translation, data entry, QC, tracking, and follow-up requests.Note:
The posting is active, with an expiry date of 06.09.2025.
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