Head of Drug Safety & Pharmacovigilance

AurigaVision AG seeks a Senior Head of Drug Safety & Pharmacovigilance in Basel to lead global safety operations, act as the Qualified Person for Pharmacovigilance (QPPV), and ensure regulatory compliance.

The company is looking for an experienced leader to direct its worldwide pharmacovigilance activities. In this role, you will serve as the Qualified Person for Pharmacovigilance (QPPV), acting as the primary liaison with health authorities while ensuring strict adherence to international drug safety standards.

Responsibilities

• Direct signal detection efforts, risk management planning, and the preparation of periodic safety update reports (PSURs).
• Create and execute pharmacovigilance strategies to support the introduction of new products.
• Administer safety databases and guarantee the prompt submission of adverse event reports.

Requirements

• Hold a medical degree (MD) or a PhD in Pharmacology, Toxicology, or a closely related discipline.
• Possess at least a decade of pharmacovigilance experience within the pharmaceutical sector.
• Demonstrate comprehensive expertise in EU GVP modules, FDA regulations, and ICH guidelines.
• Exhibit strong leadership capabilities with a track record of managing cross-functional teams.
• Maintain fluent proficiency in English.

Nice to have

• Knowledge of the German language is considered an advantage.