Senior Pharmacovigilance Specialist (Remote)

About the role

Biomapas is looking for a Senior Pharmacovigilance Specialist to join its global Pharmacovigilance team within the International QPPV department. The role supports global and local PV systems and ensures compliance with international and local PV regulations, and may include taking on additional regional or local PV responsible person roles for simple PV systems. It is fully remote and home-based in any EU country; CVs must be submitted in English.

Key responsibilities

• Act as project manager or deputy project manager for assigned projects
• Forecast accurately and help plan budgets so the QPPV office runs efficiently
• Update SOPs and act as a subject matter expert for PV in assigned company processes
• Maintain KPI reports and carry out core and standard PV activities for contractual partners
• Manage full or local PV systems and projects, including end-to-end case processing, Aggregate Safety Reports, Risk Management Plans and risk minimisation, in pre- and post-authorisation settings
• Serve as customer contact point where applicable, managing communication and escalations
• Act as EU QPPV or deputy EU QPPV where applicable
• Ensure high-quality PV service in the assigned region, timely communication with Health Authorities and inspection/audit readiness

Required profile

• Degree in biology, pharmacy, medicine or another life science field
• 4 years of experience in global pharmacovigilance
• Fluent English
• Strong organisational, prioritisation and time-management skills, able to work independently and in a team

Required skills

• Computer literacy (MS Office)
• Experience with PV databases; Veeva Vault Safety is an advantage

What we offer

• Professional growth and career opportunities
• Bonus based on annual performance
• Personal accident and business trip insurance, plus additional health insurance
• Referral policy and team building events