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. Reporting to the SVP of Clinical Development and Safety, 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.

Global Drug Safety Management

• 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

Team Leadership & Development

• Develop and sustain a high-performing drug safety team, fostering a culture of excellence, collaboration, and continuous improvement.
• Provide mentorship and leadership to support team growth, engagement, and performance.
  
  Lead ad hoc recruitment activities as needed to support evolving business and portfolio needs.
• Partner with senior leadership to drive organizational growth and support company-wide strategic initiatives.
• Represent the company at key scientific, regulatory, and industry events to enhance external visibility and partnerships.

Regulatory & Compliance

• Ensure pharmacovigilance and safety activities are conducted in full compliance with global regulatory requirements and standards (e.g., FDA, EMA, ICH, GVP).
• Collaborate with regulatory affairs on safety-related submissions, periodic safety update reports (PSURs), and labelling for post-approval products, including late-stage development assets nearing regulatory submission or launch.
• Maintain up-to-date knowledge of regulatory changes, industry trends, and scientific advancements affecting drug safety and pharmacovigilance.
• Provide strategic input into regulatory interactions and inspection readiness related to safety and risk management.

Risk Management & Decision-Making

• Provide expert safety risk assessments to support regulatory filings, lifecycle management, and commercial activities.
• Implement risk mitigation strategies for safety concerns that emerge during clinical trials or throughout the post-approval lifecycle.
• Critical leadership role in company governance forums related to safety, labelling, and benefit-risk strategy.
• Collaborate with internal stakeholders to make informed, data-driven decisions that support product safety and long-term value.

Business Development & Asset Due Diligence

• Support business development teams by providing safety expertise during the evaluation of potential in-licensing, co-development, or acquisition opportunities.
• Conduct in-depth due diligence on new assets, including assessing safety profiles, and evaluating regulatory pathways.
• Collaborate with internal teams and external partners to identify potential risks and opportunities associated with new…