Vice President of Global Drug Safety

Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.

The Vice President of Global Drug Safety is a senior leader responsible for defining and executing the company’s global pharmacovigilance strategy, with a primary focus on post-approval safety and risk management. This role blends strategic vision with operational leadership across safety surveillance activities, ensuring regulatory compliance, patient protection, and driving innovation in safety science throughout the post-approval lifecycle. This critical position plays a pivotal role in advancing the company’s global pharmacovigilance strategy and safeguarding patient safety worldwide. As a key member of the governance leadership team, the Vice President contributes to long-term growth, innovation, and excellence in risk management and safety operations. While clinical oversight is not a core responsibility, the Vice President may provide occasional support on clinical safety matters when needed.

Roles and Responsibilities

• Lead the pharmacovigilance and drug safety strategy for all post-approval products, including support for late-stage development assets nearing regulatory submission or launch where this aligns with overall safety responsibilities.
• Establish and maintain a comprehensive safety surveillance system to detect, assess, and report adverse events.
• Ensure compliance with global regulatory requirements (FDA, EMA, etc.) and guidelines (ICH, GVP) related to safety surveillance and risk management.
• Provide safety assessments for risk management plans and post-approval safety activities.
• Serve as the primary contact for regulatory authorities on safety issues and risk management strategies.
• Support GVP audit and inspection preparedness.