Pharmacovigilance Associate – English Required

Acerca de la Empresa

Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. We use innovative science and digital technologies to create transformative treatments in areas of great medical need. Our mission is to reimagine medicine to improve and extend people’s lives.

Descripción del Trabajo

We are seeking a highly motivated and detail-oriented Pharmacovigilance Associate to join our dedicated team in Roses, Spain. In this critical role, you will contribute to global drug safety by ensuring the accurate and timely processing of adverse event reports. This position requires excellent command of the English language for communication and documentation purposes, as you will be working within an international framework to uphold the highest standards of patient safety. Your work will directly impact our ability to monitor the safety profile of our medicines and comply with global regulatory requirements.

Responsabilidades Clave

• Receive, document, and process individual case safety reports (ICSRs) from various sources, including spontaneous reports, literature, and clinical trials.
• Perform data entry of adverse event information into the global safety database with accuracy and adherence to company procedures and regulatory guidelines.
• Conduct thorough case follow-up activities to obtain complete and accurate safety information.
• Prepare and submit safety reports to regulatory authorities as required, ensuring compliance with reporting timelines.
• Assist in reconciliation activities for safety data with other departments or external partners.
• Maintain up-to-date knowledge of pharmacovigilance regulations, guidelines, and company Standard Operating Procedures (SOPs).
• Participate in quality control activities and ensure data consistency and integrity.

Habilidades Requeridas

• Bachelor's degree in Pharmacy, Life Sciences, Nursing, or a related healthcare field.
• Excellent written and verbal communication skills in English are mandatory.
• Strong attention to detail and accuracy in data entry and documentation.
• Ability to work independently and as part of a team in a fast-paced environment.
• Proficiency with Microsoft Office Suite (Word, Excel, Outlook).
• Basic understanding of pharmacovigilance principles and regulatory requirements (e.g., ICH-GCP, GVP).

Cualificaciones Preferidas

• Master's degree or higher in a relevant field.
• 1-2 years of experience in pharmacovigilance or a related pharmaceutical role.
• Familiarity with safety databases such as Argus or ArisG.
• Working knowledge of Spanish is a plus, though not required.
• Experience in a multinational pharmaceutical company.

Ventajas y Beneficios

• Comprehensive health insurance plan.
• Retirement savings program.
• Opportunities for professional growth and development.
• Generous paid time off and holidays.
• Employee wellness programs.
• Access to internal training and e-learning platforms.

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