(UW-510) Case Specialist/LSO (French and Spanish speaker) VAF 325

ProductLife Group; Valladolid; Presencial; EUR 35.000 - 45.000; Jornada completa

Descripción de la vacante

A leading pharmacovigilance company in Valladolid is seeking a dedicated Case Specialist/LSO. The role involves overseeing compliance with regulatory standards, managing adverse event case reports, and acting as the Local Safety Officer. Ideal candidates will have a degree in Pharmacy or Life Sciences and at least 3 years of experience in pharmacovigilance, along with proficiency in both Spanish and French.

Formación

• Minimum 3 years of experience in pharmacovigilance, focusing on post-marketing case processing.
• Proven ability to meet deadlines and work efficiently under pressure.
• Experience in client communication related to pharmacovigilance.

Responsabilidades

• Collect and assess reports of adverse events from various sources.
• Create and maintain detailed case reports in pharmacovigilance databases.
• Act as the Local Safety Officer on behalf of PLG clients in Spain.

Conocimientos

Fluency in Spanish

Fluency in French

Attention to detail

Organization

Reliability

Educación

Degree in Pharmacy or Life Sciences

Herramientas

Pharmacovigilance databases (e.g., Argus, SafetyEasy)

Microsoft Office

Descripción del empleo

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.

Responsibilities Case Management & Review Collect 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 & Compliance Create 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 Communication 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. Audits & Inspections Participate in audits, inspections, and contribute to action plans to maintain compliance with regulatory and company standards.

Experience Degree in Pharmacy or Life Sciences. Minimum 3 years of experience in pharmacovigilance (PV),



with a focus on post-marketing case processing and QC. Proven ability to meet deadlines and work efficiently under pressure. Experience in client communication related to pharmacovigilance matters. Knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practices (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 handling local case management activities (e.g., translation, data entry, QC, tracking, follow-up requests). Fluency in Spanish and French

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https://www.kitempleo.es/empleo/219621020/uw-510-case-specialist-lso-french-and-spanish-speaker-vaf-325-valladolid/?utm_source=html