Pharmacovigilance Specialist (Medical/Clinical Safety)

About the role

Supports a worldwide safety team by handling safety data, reports and compliance so that adverse event information is collected, assessed and reported correctly.

What you will do

• Process individual case safety reports and clinical trial serious adverse events, including database entry, tracking, narratives, follow-up
• Reconcile safety data and represent safety and pharmacovigilance in project and study team meetings
• Plan, coordinate and quality check aggregate safety reports and help prepare regulatory safety documents
• Oversee local handling and submission of periodic safety reports, risk management plans and risk minimisation work
• Serve as the local pharmacovigilance contact or backup around the clock and track national and regional regulations
• Take part in inspections and audits, including follow-up support

What they look for

• University degree in a life science field
• Four or more years in pharmacovigilance, clinical safety and clinical development, with expert knowledge of safety legislation
• Familiarity with international rules such as ICH, EU GVP modules and FDA requirements
• Experience with safety databases such as Argus or ArisG and with MedDRA coding
• Fluent English plus the local country language
• Strong attention to detail, time management and problem solving, with openness to automation and new tools

Nice to have

• Project management experience

Benefits

• Career growth and professional development opportunities
• International team and working environment
• Annual performance bonus
• Personal accident and business trip insurance
• Additional health insurance, remote working, flu vaccines and a referral reward scheme