Senior PV & Safety Lead - Hybrid Madrid

Syneos Health, Inc.; Madrid; Hybride; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Syneos Health, Inc. in Madrid seeks a Senior Safety and Pharmacovigilance Specialist to manage PV program delivery, including ICSR processing, literature screening, MedDRA coding, and SPVG data activities.

You will ensure timely safety reporting, maintain data quality, and support SPOR/IDMP workstreams while collaborating with cross-functional teams in a hybrid work setup. The role requires a life science degree (or equivalent), strong knowledge of ICH GCP/GVP, and proficiency with safety

Qualifications

• Bachelor’s degree or equivalent in life science, nursing, pharmacy or related field.
• Strong knowledge of regulatory safety requirements (ICH GCP, GVP).
• Proficiency with safety databases and MS Office Suite.
• Excellent written and spoken communication; ability to work independently and in a team.

Responsabilités

• Oversee pharmacovigilance program delivery, including ICSR handling and reporting.
• Coordinate SPOR/IDMP activities and safety data quality reviews.
• Lead data management tasks, including coding, validation, and medical terminology applications.
• Prepare expedited and periodic safety reports in compliance with regulatory guidelines.

Connaissances

Safety databases

Medical terminology

ICH GCP

GVP

MS Office

Communication skills

Independent work

Travel up to 10%

Formation

Bachelor’s degree in life science / nursing / pharmacy

Outils

SPVG safety systems

Description du poste

Syneos Health, Inc. in Madrid seeks a Senior Safety and Pharmacovigilance Specialist to manage PV program delivery, including ICSR processing, literature screening, MedDRA coding, and SPVG data activities.

You will ensure timely safety reporting, maintain data quality, and support SPOR/IDMP workstreams while collaborating with cross-functional teams in a hybrid work setup. The role requires a life science degree (or equivalent), strong knowledge of ICH GCP/GVP, and proficiency with safety