Pharmacovigilance Specialist — Hybrid & Temporary

Grifols, S.A; Sant Cugat del Vallès; Híbrido; EUR 42.000 - 56.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid Model

Flexible schedule

Descripción de la vacante

Grifols, S.A invites a Clinical Drug Safety Officer for a temporary position. The role focuses on safety data collection, adverse event review, and acting as the pharmacovigilance representative for clinical studies. Strong communication and collaboration with clinical teams are essential.

You will contribute to safety management plans, DSUR/PSUR/RMP preparation, and support audits. Fluency in Spanish and English, plus a health sciences degree and CRO/pharma experience, are required.

Formación

• Bachelor’s degree in health sciences (pharmacy, nursing, medicine, veterinary) or bioscience (biochemistry, biotechnology, biology) or similar.
• 1 year’s experience in a similar position in a CRO or pharmaceutical company.
• Fluent in Spanish and English.
• High attention to detail with meticulousness.

Responsabilidades

• Participate in safety data collection, review, processing, evaluation and compilation.
• Process adverse event case reports (mainly Serious Adverse Events from clinical trials) with follow-up and submissions per timelines.
• Provide technical oversight and be the pharmacovigilance representative for clinical studies.
• Subject Matter Expert for documents pertaining to clinical studies.
• Contribute to pharmacovigilance activities in collaboration with clinical teams and business partners.
• Develop safety management plans, SAE forms, safety reporting training, AE data reconciliation, and support regulatory inquiries.
• Contribute to benefit/risk assessment based on quality data management.
• Prepare Development Safety Reports (DSURs), PSURs and Risk Management Plans (RMPs).
• Create/update pharmacovigilance procedures and support audits/inspections.

Conocimientos

Spanish fluency

English fluency

Attention to detail

Communication skills

Team player

Time management

Educación

Health sciences degree

Descripción del empleo

Grifols, S.A invites a Clinical Drug Safety Officer for a temporary position. The role focuses on safety data collection, adverse event review, and acting as the pharmacovigilance representative for clinical studies. Strong communication and collaboration with clinical teams are essential.

You will contribute to safety management plans, DSUR/PSUR/RMP preparation, and support audits. Fluency in Spanish and English, plus a health sciences degree and CRO/pharma experience, are required.