Senior Safety Physician - Global Pharmacovigilance Leader

Shionogi Europe; Amsterdam; Presencial; EUR 110.000 - 170.000; Jornada completa

Descripción de la vacante

Shionogi Europe is seeking a Senior Safety Physician to join our European Drug Safety team. The role involves hands-on pharmacovigilance across development and marketed products, providing medical expertise and regulatory input in an international setting.

You will contribute to signal management, regulatory responses, and safety studies, working with colleagues across Europe and globally. English fluency and strong GVP/GCP knowledge are essential.

Formación

• Medical degree and license for practice.
• 5+ years in pharma, mainly pharmacovigilance.
• Strong knowledge of GVP and GCP.
• Good understanding of EU/global PV regulations.
• Experience with RMPs, PSURs and PASS.

Responsabilidades

• Provide PV input into MAA submissions and safety variations.
• Medically review ICSRs and aggregate listings.
• Contribute to signal management activities for developmental and marketed products.
• Plan and maintain EU RMPs, PSURs, DSURs, and PASS studies.
• Provide safety input into study protocols and CSRs.
• Support regulatory procedures and safety communications.

Conocimientos

Medical degree

Pharmacovigilance experience

GVP/GCP knowledge

Regulatory knowledge

Cross-functional collaboration

English fluency

Educación

Medical degree

Descripción del empleo

Shionogi Europe is seeking a Senior Safety Physician to join our European Drug Safety team. The role involves hands-on pharmacovigilance across development and marketed products, providing medical expertise and regulatory input in an international setting.

You will contribute to signal management, regulatory responses, and safety studies, working with colleagues across Europe and globally. English fluency and strong GVP/GCP knowledge are essential.