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

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

Descripción de la vacante

A leading company in pharmacovigilance seeks a Case Specialist / Local Safety Officer to join their team in Cartagena, Spain. The role involves overseeing case management, ensuring compliance with regulatory standards, and communicating with local authorities. The ideal candidate will have a relevant degree, at least 3 years of experience in pharmacovigilance, and fluency in both Spanish and French.

Formación

• 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.
• Knowledge of GCP and GVP.

Responsabilidades

• Collect and assess reports of adverse events from healthcare providers and patients.
• Create and maintain detailed case reports, ensuring compliance with GVP.
• Serve as point of contact with local regulatory authorities.

Conocimientos

Attention to detail

Organizational skills

Reliability

Client communication

Fluency in Spanish

Fluency in French

Educación

Degree in Pharmacy

Degree in Life Sciences

Herramientas

PV databases (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 point of contact with local regulatory authorities on a 24/7 basis, as required.
3. Stay updated 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 PV 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.