For our Global Safety and Pharmacovigilance department, we are looking for a

Senior Director, Head Global PV Compliance (m/f/x)

R-246568

Fulltime / permanent/ non-tariff

As Senior Director, Head Global PV Compliance you will be a key leader and influencer who drives cross-functional strategies to demonstrate a healthy CSL PV System for CSL Behring, CSL Seqirus and CSL Vifor.

The Opportunity

• You will be organizationally and operationally responsible for compliance oversight of key PV system-relevant processes (including ICSR compliance) across the 3 CSL businesses and in partnership with interface functions and the International Pharmacovigilance organization from each of the 3 CSL businesses.
• One of your main responsibilities will be to ensure that the entire organization is compliant with applicable pharmacovigilance regulations and requirements, ICH GCP guidelines, international standards, and company policies relating to pharmacovigilance and risk management activities globally as well as locally.
• As senior representative in cross-functional teams and a key decision-maker on PV compliance and PV system oversight, you will drive effective and synergistic engagement of all stakeholders on performance and compliance oversight and work in close cooperation with the Global/EU-QPPV and Head of International Pharmacovigilance.

• Qualified to full university degree, ideally relating to life or natural sciences, or pharmacy
• Ten years global pharmaceutical / biotechnology industry experience,
• At least five years in a role in pharmacovigilance, with broad overview of all aspects of a PV system and specific experience in terms of other GxP areas, in particular GCP and GMP
• Experience and proven success in addressing and managing complex issues globally including interfacing with external regulatory bodies
• Proven experience and understanding of Pharmacovigilance Quality Systems
• Demonstrated leadership capabilities and cross-functional senior management engagement
• Demonstrated ability and experience with GCP/GMP auditing processes
• In depth awareness/knowledge of industry regulations and drug safety practices, with emphasis on local and international guidelines
• Proven managerial skills, including budget and resource management, staff training and development

• Excellent income potential and extended benefits
• Two additional leave days for your personal wellbeing
• Family services such as psychological support, legal advice, family care services and more for you and your direct family
• Hybrid working models