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A leading company is seeking a dedicated Case Specialist / Local Safety Officer with proficiency in French and Spanish to manage pharmacovigilance activities. This role requires a strong compliance background and at least 3 years of experience in post-marketing case processing. The candidate will ensure adherence to regulatory standards and manage local case management tasks.
PLG is looking for a dedicated Case Specialist / LSO (French and Spanish speaker) to join our hub to oversee and work closely with our PV team to ensure compliance with regulatory standards and accurate safety data.
Ensure quality control (QC) for post-marketing cases.
Create and maintain detailed case reports, ensuring accurate documentation in pharmacovigilance databases (Argus, SafetyEasy).
Ensure compliance with Good Pharmacovigilance Practices (GVP) and local regulatory requirements.
Act 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.
Act as point of contact with local regulatory authorities on a 24 / 7 basis, as required
Responsible for keeping up to date with local regulatory requirements
Conduct local regulatory intelligence screening, tracking updates from health authorities.
Support and contribute to local pharmacovigilance (PV) activities performed by the Pharmacovigilance / Medical Information teams.
Minimum 3 years of experience in pharmacovigilance (PV), with a focus on post-marketing case processing and QC.
Hands-on experience with pharmacovigilance databases (e.g., Knowledge of local Spain and international regulations.
Proficiency in Microsoft Office (Word, Excel, PowerPoint).
Experience handling local case management activities (e.g., translation, data entry, QC, tracking, follow-up requests).
Fluency in Spanish and French