Senior Vice President - Global Head of Safety Risk Management

The Opportunity

The Global Head of Safety Risk Management provides strategic, scientific, and operational leadership for the global pharmacovigilance and safety risk management function across the entire product lifecycle, from early development through post-marketing and lifecycle management.

This role ensures the proactive identification, assessment, minimization, and transparent communication of safety risks to protect patients, support regulatory compliance, and enable the successful development and commercialization of innovative medicines. The position partners closely with Research and Early Development, PD Clinical, PD Regulatory, PD Quality and PD Global Med Affairs, Local Medical Affairs, Commercial functions, and external stakeholders to ensure a robust, forward-looking positive benefit–risk profile for all products.

The role is accountable for meeting global Health Authority expectations and for advancing state of the art safety science, data-driven decision-making, and a strong safety culture across the organization.

• Define and execute a global, lifecycle-based safety risk management strategy aligned with corporate and development objectives.
• Ensure consistent application of pharmacovigilance and safety risk management processes across development, marketed products, and divestments.
• Drive a proactive benefit-risk culture:
  Continue to evolve the organization beyond a traditional risk-centric focus toward a sophisticated, science-based benefit-risk framework; ensure that safety data is leveraged not just for compliance, but as a strategic asset to optimize the therapeutic window and enable the development of transformative medicines for patients.
• Serve as enterprise safety leader and Chair of the Drug Safety Committee (or equivalent governance body).
• Act as a senior advisor to executive leadership on benefit–risk, emerging safety issues, and regulatory risk.
• Lead or oversee the delegation of the organization’s medical-safety response during global crises or significant emerging public health concerns.

• Ensure global compliance with pharmacovigilance regulations and guidelines (including FDA, EMA, PMDA, ICH, CIOMS).
• Oversee core pharmacovigilance processes, including:
  • Individual case safety report (ICSR) management
  • Aggregate reporting and benefit–risk evaluation
  • Signal detection across all data sources (clinical, post-marketing, real-world data)
  • Risk management plans and post-authorization safety studies
• Ensure the EU Qualified Person for Pharmacovigilance (QPPV) can fulfill their legal mandate and global PV system master file requirements are fully met.
• Lead interactions with global Health Authorities on safety matters and support inspections, audits, and issue resolution.

• Advance safety science through the use of real-world evidence, advanced analytics, and innovative methodologies.
• Lead the strategy for AI-driven automation in pharmacovigilance to increase efficiency and predictive safety capabilities.
• Drive continuous improvement of safety signal evaluation, benefit–risk frameworks, and decision-making models.
• Foster external collaborations with academia, industry consortia, professional societies, and patient organizations as appropriate.

• Partner with Clinical Development, Regulatory Affairs, Quality, Global and Local Medical Affairs, Commercial, and Affiliates to integrate safety into decision-making.
• Support regulatory submissions and labeling strategies with robust safety assessments.
• Oversee safety-related training and communication for internal stakeholders, including field medical and commercial teams.
• Establish and manage effective safety governance with current and potential licensing partners and strategic alliances.

• Lead and develop a high-performing, globally distributed safety organization.
• Oversee the budget of the local and safety organization, including strategic vendor management and optimization of outsourcing partnerships.
• Build future-ready capabilities through strategic workforce…