The Position

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.

Key Responsibilities

Strategic Safety Leadership

• 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.

Pharmacovigilance & Regulatory Compliance

• 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.

Safety Science & Innovation

• 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.

Cross-Functional & External Collaboration

• 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.

Organizational Leadership & Talent Development

• 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 planning, succession planning, and selective outsourcing.
• Promote a culture of accountability, inclusion, continuous learning, and patient-centricity.
• Establish clear performance metrics, dashboards, and governance to ensure transparency and continuous improvement.

Enterprise Contribution

• Contribute as a senior leader within the Product Development / Medical organization leadership team.
• Role model company values and leadership behaviors.
• Support enterprise-wide risk management, quality, and compliance initiatives.

People Leadership

• Direct reports: Global leadership team and key functional heads
• Indirect reports: Large global organization across regions and affiliates (hundreds of employees)

Qualifications

Education

• MD or equivalent medical degree from an accredited institution (required) and speciality or subspecialty board certification is a plus
• PhD or advanced scientific degree (desired)

Experience & Expertise

• Significant experience and track record in pharmaceutical or biotechnology drug development, including proven leadership experience in pharmacovigilance and safety risk management.
• Deep understanding of global drug development and post-marketing surveillance.
• Demonstrated experience interacting directly with global Health Authorities (FDA, EMA, NMPA or PMDA).
• Proven track record of leading large, complex, multicultural organizations and driving transformation.
• Strong expertise in benefit–risk assessment, regulatory strategy, and safety governance.
• Experience with digital transformation, real-world evidence, and data-driven safety approaches is highly desirable.

Leadership & Competencies

• Strategic and systems thinker with strong scientific judgment.
• Ability to communicate complex safety topics clearly to senior leadership and external stakeholders.
• Strong people leadership, coaching, and talent development capabilities.
• Highly collaborative, effective stakeholder management skills and enterprise thinker
• Strong decision maker and problem solver - depending on the issue as single decision maker, consent or consensus driver
• High integrity and unwavering commitment to patient safety.
• Excellent written and verbal communication skills in English.

Travel

• Availability to navigate the demands leading a large global organization, including extensive international travel (25%+) and early or late in-person meetings that accommodate global time zones.

This job description reflects a modern, globally integrated pharmacovigilance leadership role, emphasizing patient-centricity, regulatory excellence, digital innovation, and enterprise leadership.

Note: Succession talents have been identified, however we welcome applications from candidates who feel they meet/exceed the above-outlined criteria.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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