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

ProductLife Group; Salamanca; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

Une entreprise leader dans la pharmacovigilance recherche un Spécialiste des Cas et Responsable Local de Sécurité afin d'assurer la conformité réglementaire en Espagne. Le candidat idéal sera titulaire d'un diplôme en pharmacie ou sciences de la vie, avec au moins 3 ans d'expérience en pharmacovigilance. Ce rôle implique une étroite collaboration avec l'équipe de pharmacovigilance pour garantir l'intégrité des données de sécurité et le respect des normes réglementaires.

Formación

• Minimum 3 ans d'expérience en pharmacovigilance.
• Fluency en espagnol et français est requise.
• Expérience avec les bases de données de pharmacovigilance obligatoire.

Responsabilidades

• Gérer les rapports d'événements indésirables et effectuer des revues médicales.
• Créer des rapports de cas détaillés et s'assurer de la conformité.
• Actuer en tant qu'agent de sécurité local pour les clients.

Conocimientos

Connaissance des GCP et GVP

Communication client

Attention aux détails

Educación

Diplôme en pharmacie ou sciences de la vie

Herramientas

Argus

SafetyEasy

Microsoft Office

Descripción del empleo

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.

Responsibilities

1. Case Management & Review
2. Collect and assess reports of adverse events from healthcare providers, patients, and healthcare systems.
3. Perform medical review of safety reports, analyzing patient history, dosage, and the timing of adverse events.
4. Query and conduct further assessments when necessary to clarify the nature of adverse reactions.
5. Ensure quality control (QC) for post-marketing cases.

Documentation & Compliance

1. Create and maintain detailed case reports, ensuring accurate documentation in pharmacovigilance databases (Argus, SafetyEasy).
2. Submit safety reports to regulatory agencies such as the FDA, EMA, and relevant national authorities.
3. Ensure compliance with Good Pharmacovigilance Practices (GVP) and local regulatory requirements.

Regulatory & Client Communication

1. 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.
2. Serve as the point of contact with local regulatory authorities, available 24/7 as required.
3. Keep up to date with local regulatory requirements and conduct local regulatory intelligence screening.
4. Support and contribute to local PV activities performed by the Pharmacovigilance / Medical Information teams.

Audits & Inspections

1. Participate in audits and inspections.
2. Contribute to action plans to maintain compliance with regulatory and company standards.

Experience & Qualifications

• Degree 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 (translation, data entry, QC, tracking, follow-up).
• Fluency in Spanish and French.