Qualified Person for Pharmacovigilance

Qualified Person for Pharmacovigilance

Permanent, Hybrid

Location: Netherlands

Driven by their mission to transform the lives of patients with rare, life-threatening diseases, this biopharma develop and commercialise innovative protein replacement therapies and precision medicines.

Reporting to the VP of Global Pharmacovigilance, as QPPV, you will play a critical role in ensuring patient safety and regulatory compliance within the European Economic Area (EEA).

Key Responsibilities:

• Act as the pharmacovigilance contact for the EMA and NCA’s
• Oversee the PV system, ensuring compliance and continuous improvement
• Ensure accurate and timely safety reporting (PSMF, PSUR, DSUR, RMPs)
• Maintain oversight of risk management, safety signal detection, and benefit-risk evaluation
• Support regulatory action, audits, and inspections as a GVP lead
• Collaborate with internal teams and external partners to ensure high-quality pharmacovigilance practices

Requirements:

• 5+ years of solid industry experience in pharmacovigilance & drug safety (both for development and marketed products)
• Previous QPPV or Deputy QPPV experience
• Strong knowledge of EU PV legislation, GVP modules, and international PV standards
• Ability to interpret safety data and drive regulatory decision-making