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

ProductLife Group; Asturias; Presencial; EUR 40.000 - 55.000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical sector is seeking a dedicated Case Specialist / LSO fluent in French and Spanish. This role involves overseeing compliance with regulatory standards, managing safety reports, and facilitating communication with local regulatory bodies. The ideal candidate will have a degree in Pharmacy or Life Sciences and at least three years of experience in pharmacovigilance, exhibiting strong attention to detail and organizational skills.

Formación

• Minimum 3 years of experience in pharmacovigilance focused on case processing.
• Proficient in Spanish and French.
• Knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practices (GVP).

Responsabilidades

• Collect and assess adverse event reports.
• Maintain detailed case reports in pharmacovigilance databases.
• Act as Local Safety Officer and point of contact for regulatory authorities.

Conocimientos

Attention to detail

Organization

Client communication

Regulatory knowledge

Educación

Degree in Pharmacy or Life Sciences

Herramientas

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