Senior Safety Physician - Global Pharmacovigilance Leader

Shionogi; Amsterdam; On-site; GBP 110,000 - 140,000; Full time

Job summary

Shionogi is seeking an experienced (Senior) Safety Physician to join our European Drug Safety team. The role covers pharmacovigilance activities across both development and marketed products, providing medical judgment and regulatory input in a hands‑on, international environment.

You will review ICSRs and listings, contribute to signal management, design EU RMPs and PSURs, and support PASS and real‑world studies while collaborating with colleagues across Europe and beyond.

Qualifications

• Medical degree and registration/licence to practice in the location.
• 5+ years in the pharmaceutical industry with pharmacovigilance focus across development and marketed products.
• Strong knowledge of GVP, GCP and relevant ICH guidance.
• Good knowledge of European and global pharmacovigilance regulations.
• Experience with EU RMPs, PSURs, PASS and regulatory commitments from a PV perspective.
• Clinical trial and GCP experience.
• Experience working in cross‑functional teams.
• Strong organisational, planning, prioritisation and problem‑solving skills.
• Ability to manage complex assignments to demanding timelines.
• Excellent written and verbal communication across countries.

Responsibilities

• Provide PV input into Marketing Authorisation Applications and safety variations.
• Medical review of individual case safety reports (ICSRs) and aggregate listings.
• Contribute to signal management for developmental and marketed products.
• Plan, author and maintain EU RMPs and periodic safety reports (PSURs/PBRERs/DSURs).
• Contribute to PASS and real‑world evidence study design and execution.
• Provide medical safety input into study protocols, ICFs and CSR documents.
• Support safety communications and regulatory procedures across geographies.
• Act as Global Drug Safety Representative for assigned products when required.
• Support inspection readiness for GVP and GCP audits and responses.

Skills

Pharmacovigilance

GVP knowledge

Cross-functional teamwork

Medical judgment

Regulatory know‑how

English proficiency

Education

Medical degree

Medical registration/licence

Job description

Shionogi is seeking an experienced (Senior) Safety Physician to join our European Drug Safety team. The role covers pharmacovigilance activities across both development and marketed products, providing medical judgment and regulatory input in a hands‑on, international environment.

You will review ICSRs and listings, contribute to signal management, design EU RMPs and PSURs, and support PASS and real‑world studies while collaborating with colleagues across Europe and beyond.